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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): November 12, 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 November 12, 2025, Nuwellis, Inc. (the “Company”) issued a press release reporting its financial results for the three and nine months ended September 30, 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 November 12, 2025, reporting the financial results of Nuwellis, Inc. for the three and nine months ended September 30, 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: November 12, 2025
NUWELLIS, INC.
   
 
By:
/s/ John L. Erb
  
 
Name:
John L. Erb
  
 
Title:
President, Chief Executive Officer,
Interim Chief Financial Officer
 


EX-99.1 2 ef20058643_ex99-1.htm EXHIBIT 99.1
Exhibit 99.1

Nuwellis Reports Third Quarter 2025 Results and Continued Operational Momentum

Company delivers steady performance and achieves key milestones across critical care, pediatrics, and hospital-based outpatient therapy

MINNEAPOLIS, MN – November 12, 2025 – Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardio-renal conditions, addressing the critical interplay between the heart and kidneys, today reported financial results for the third quarter ended September 30, 2025 and provided a business update on recent milestones advancing the company’s cardiorenal growth strategy.

Third Quarter 2025 Highlights


 •
Total revenue of $2.2 million, down 6% year-over-year and up 29% sequentially, reflecting increased consumable utilization and stronger U.S. console sales on a sequential quarter basis. On a pro-forma basis, revenue grew approximately 7% year-over-year, after excluding one-time SeaStar medical revenue of $0.2 million in the prior year quarter and a $0.1 million year-over-year decrease in international revenue associated with the commencement of international wind-down activities in the third quarter.

•
All customer categories achieved year-over-year growth in circuit sales, highlighting broader adoption across critical care, heart failure, and pediatrics.

•
First Aquadex® therapies delivered in a hospital-based outpatient setting, under new CMS code. A major step forward in expanding access to safe, efficient ultrafiltration therapy.

•
U.S. launch of new 24-hour circuit and dual-lumen extended-length catheter, enhancing provider flexibility across inpatient and hospital-based outpatient programs.

•
Pediatric product development accelerated through an NIH-funded collaboration to advance the Vivian™ pediatric CRRT system and a newly issued U.S. patent supporting broader platform innovation.

•
Initiated manufacturing transition to KDI Precision Manufacturing and exit of international operations to focus on U.S. market growth.

•
Raised $1.9 million through ATM facility in the quarter.

Management Commentary

“Our third quarter results reflect disciplined execution and meaningful progress toward building a more focused, U.S.-driven business,” said John Erb, Chairman and Chief Executive Officer of Nuwellis. “We continue to strengthen our leadership in precision fluid management across critical care, pediatrics, and hospital-based outpatient therapy. With the launch of our new 24-hour circuit and successful early hospital-based outpatient treatments, we are expanding how and where Aquadex therapy can be delivered to improve patient outcomes.”


Third Quarter 2025 Financial Results

Total revenue for the third quarter of 2025 was $2.2 million, compared to $2.4 million in the prior year quarter. On a pro-forma basis, revenue grew approximately 7% year-over-year, after excluding one-time SeaStar medical revenue of $0.2 million in the prior year period and a $0.1 million decrease in international revenue due to the commencement of international wind-down activities in the third quarter.

Sequentially, revenue increased 29% from the second quarter, driven by higher consumable utilization and increased U.S. console placements.

Gross margin was 65.2%, compared to 70.0% in the prior year quarter, driven by unfavorable manufacturing utilization in the first half of fiscal year 2025, which was recognized in Costs of Sales in the third quarter.

Operating expenses totaled $4.1 million, up 30% year-over-year, reflecting increased investment in rebuilding the U.S. sales force to historical headcount levels and additional investments in sustaining engineering and quality systems.

Operating loss was $2.7 million, compared to $1.5 million last year.

The company ended the quarter with $3.1 million in cash and cash equivalents and remains debt-free.

Conference Call and Webcast Information

Nuwellis management will host a conference call today, November 12, 2025, to discuss financial results and provide a business update.

To access the live webcast, please visit the Investors page at https://ir.nuwellis.com. Alternatively, participants can join the live conference call by dialing 1-800-274-8461 (U.S.) or 1-203-518-9814 (international) and using the conference ID: NUWEQ3. A replay will be available following the call on the Investors page on the company’s website.

For more information, visit www.nuwellis.com.

About Nuwellis Nuwellis, Inc. (Nasdaq: NUWE) is a medical technology company advancing precision fluid management therapies to improve recovery and outcomes for cardio-renal syndrome patients. Through our Aquadex® SmartFlow system, we make fluid balance measurable, controllable, and consistent—supporting clinicians with technology designed for accuracy and confidence in care. Headquartered in Minneapolis, MN, with a wholly owned subsidiary in Ireland, Nuwellis is redefining the standard for fluid management. For more information visit www.nuwellis.com or visit us on LinkedIn or X, formerly known as Twitter.
 
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 health care provider, within an outpatient or inpatient clinical setting, under physician prescription, both having received training in extracorporeal therapies.
 

About Vivian Vivian is a purpose-built pediatric CRRT system designed for neonates and children. The platform targets an extracorporeal blood volume of 29–67 mL and features integrated hematocrit and SvO₂ sensors for real-time monitoring. Vivian brings three therapies—Ultrafiltration (UF), Continuous Veno-Venous Hemofiltration (CVVH), and Continuous Veno-Venous Hemodialysis (CVVHD)—onto a single platform with closed-loop ultrafiltration control tailored to patient weight. A guided, clinician-informed interface with on-screen prompts streamlines setup and reduces training burden, while a 6-port circuit provides flexible vascular-access options. Intended for patients 2.5–20 kg, Vivian was developed with direct input from pediatric ICU and nephrology teams to prioritize safety, precision, and simplicity for the most fragile patients.

Disclaimer: Vivian is an investigational device, under development, and not available for sale. Features and specifications are subject to change.

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 the new market opportunities and anticipated growth in 2025 and beyond. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with our ability to execute on our commercialization strategy, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. Nuwellis does not assume any obligation to publicly update or revise any forward-looking statements, whether due to new information, future events or otherwise.
 
For further information, please contact:
 
Investor Relations:
ir@nuwellis.com

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


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

   
September 30,
2025
    
December 31,
2024
  
ASSETS
  
(Unaudited)
        
Current assets
            
Cash and cash equivalents
  
$
3,094
    
$
5,095
  
Accounts receivable
    
1,141
      
1,727
  
Inventories, net
    
2,189
      
1,718
  
Other current assets
    
776
      
315
  
Total current assets
    
7,200
      
8,855
  
Property, plant and equipment, net
    
414
      
478
  
Operating lease right-of-use asset
    
349
      
510
  
Other assets
    
21
      
21
  
TOTAL ASSETS
  
$
7,984
    
$
9,864
  
                 
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY
                
Current liabilities
                
Accounts payable and accrued liabilities
  
$
2,668
    
$
1,640
  
Accrued compensation
    
523
      
640
  
Current portion of operating lease liability
    
255
      
238
  
Other current liabilities
    
76
      
41
  
Total current liabilities
    
3,522
      
2,559
  
Warrant liabilities
    
420
      
468
  
Operating lease liability
    
128
      
307
  
Total liabilities
    
4,070
      
3,334
  
Commitments and contingencies
                
                 
Mezzanine Equity
Series J Convertible Preferred Stock as of September 30, 2025 and December 31, 2024, par value $0.0001 per share; authorized 600,000 shares, issued and outstanding 127 and 102, respectively
    
6
      
2
  
Stockholders’ equity
                
Series A junior participating preferred stock as of September 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 September 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 September 30, 2025 and December 31,2024, par value $0.0001 per share; authorized 100 shares, issued and outstanding 34 and 0 shares, respectively
    
—
      
—
  
Preferred stock as of September 30, 2025 and December 31, 2024, par value
$0.0001 per share; authorized 39,352,000 shares, none outstanding
    
—
      
—
  
Common stock as of September 30, 2025 and December 31, 2024, par value
$0.0001 per share; authorized 100,000,000 shares, issued and outstanding
1,364,970 and 104,142, respectively
    
—
      
—
  
Additional paid‑in capital
    
317,852
      
305,366
  
Accumulated other comprehensive income:
                
Foreign currency translation adjustment
    
(54
)
    
(47
)
Accumulated deficit
    
(313,890
)
    
(298,791
)
Total stockholders’ equity
    
3,908
        6,528  
TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY
  
$
7,984
     $
 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
September 30
    
Nine months ended
September 30
  
   
2025
    
2024
    
2025
    
2024
  
Net sales
  
$
2,217
    
$
2,367
    
$
5,846
    
$
6,418
  
Cost of goods sold
    
772
      
711
      
2,376
      
2,097
  
Gross profit
    
1,445
      
1,656
      
3,470
      
4,321
  
Operating expenses:
                                
Selling, general and administrative
    
3,539
      
2,702
      
10,305
      
10,544
  
Research and development
    
603
      
486
      
1,828
      
2,378
  
Total operating expenses
    
4,142
      
3,188
      
12,133
      
12,922
  
Loss from operations
    
(2,697
)
    
(1,532
)
    
(8,663
)
    
(8,601
)
Other income (expense), net
    
4
      
8
      
21
      
(87
)
Financing expense
    
—
      
—
      
(10,553
)
    
(5,607
)
Change in fair value of warrant liabilities
    
3,161
      
3,882
      
4,101
      
4,602
  
Income (loss) before income taxes
    
468
      
2,358
      
(15,094
)
    
(9,693
)
Income tax expense
    
—
   
—
      
(5
)
    
(4
)
Net income (loss)
  
$
468
    
$
2,358
    
$
(15,099
)
  
$
(9,697
)
Deemed dividend attributable to Series J Convertible Preferred Stock
    
1
      
—
      
3
      
541
  
Net income (loss) attributable to common shareholders
  
$
469
    
$
2,358
    
$
(15,096
)
  
$
(9,156
)
                                 
Basic and diluted income (loss) per share
  
$
0.56
    
$
73.23
    
$
(39.51
)
  
$
(142.11
)
                                 
Weighted average shares outstanding – basic and diluted
    
836,386
      
204,710
      
382,123
      
68,237
  
                                 
Other comprehensive loss:
                                
Net income (loss)
   $ 468
    $
2,358
     $
(15,099
)
   $
(9,697
 )
Foreign currency translation adjustments
  
$
(1
)
  
$
(4
)
  
$
(7
)
  
$
(15
)
Total comprehensive income (loss)
  
$
467
    
$
2,354
    
$
(15,106
)
  
$
(9,712
)


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

   
Nine months ended
September 30
  
   
2025
    
2024
  
Operating Activities:
            
Net loss
  
$
(15,099
)
  
$
(9,697
)
Adjustments to reconcile net loss to cash flows used in operating activities:
                
Depreciation and amortization
    
166
      
227
  
Stock-based compensation expense
    
103
      
374
  
Change in fair value of warrant liabilities
    
(4,101
)
    
(4,602
)
Financing expense
    
10,553
      
5,607
  
Amortization of operating lease right-of-use asset
    
161
      
150
  
Changes in operating assets and liabilities:
                
Accounts receivable
    
586
      
658
  
Inventory, net
    
(471
)
    
120
  
Other current assets
    
(461
)
    
(275
)
Other assets and liabilities
    
35
      
(3
)
Lease liability
    
(162
)
    
(160
)
Accounts payable and accrued expenses
    
910
      
(486
)
Net cash used in operating activities
    
(7,780
)
    
(8,087
)
                 
Investing Activities:
                
Purchases of property and equipment
    
(102
)
    
(37
)
Net cash used in investing activities
    
(102
)
    
(37
)
                 
Financing Activities:
                
Issuance of common stock and warrants from offering, net
    
3,999
      
2,403
  
Issuance of common stock from ATM, net
    
1,889
      
—
  
Proceeds from the exercise of Series J Convertible Preferred Warrants
    
—
      
501
  
Proceeds from the exercise of April 2024 Warrants
    
—
      
1,182
  
Issuance of July and August 2024 Common Stock and Warrants
    
—
      
2,160
  
Net cash provided by financing activities
    
5,888
      
6,246
  
                 
Effect of exchange rate changes on cash
    
(7
)
    
(15
)
Net decrease in cash and cash equivalents
    
(2,001
)
    
(1,893
)
Cash and cash equivalents - beginning of period
    
5,095
      
3,800
  
Cash and cash equivalents - end of period
  
$
3,094
    
$
1,907
  

Supplemental cash flow information
Reclassification of April 2024 warrants to equity
  
$
—
    
$
4,217
  
Issuance of Series J Preferred Stock for exercise of Warrants
  
$
—
    
$
1,857
  
Series A warrants conversion to equity
  
$
8,439
    
$
—
  
Series B warrant exercises
  
$
2,055
    
$
—
  
Issuance of Common Stock for conversion of Series J Preferred Stock
  
$
—
    
$
1,535
  
Issuance of Common Stock for conversion of Series F-1 Preferred Stock
  
$
1,100
    
$
—
  
Deemed dividend on Series J Preferred Stock
  
$
3
    
$
(541
)
Common stock offering costs included in prepaids
  
$
—
    
$
306