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): August 13, 2026

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 August 13, 2026, Nuwellis, Inc. (the “Company”) issued a press release reporting its financial results for the three and six months ended June 30, 2026. 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 August 13, 2026, reporting the financial results of Nuwellis, Inc. for the three and six months ended June 30, 2026.

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: August 13, 2026
NUWELLIS, INC.



By:
/s/ Mike McCormick

Name:
Mike McCormick

Title:
Chief Executive Officer


Exhibit 99.1
 
 

FOR IMMEDIATE RELEASE
August 13, 2026

Nuwellis Reports Second Quarter 2026 Financial Results and Business Highlights Focused on Double Digit Revenue Growth and Expanded Gross Margin
 
Recent capital raise and warrant exercises extend cash runway through second quarter of 2027

Conference call begins at 9:00 a.m. Eastern time today

MINNEAPOLIS – August 13, 2026 – Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardiorenal conditions, today reported financial results for the three and six months ended June 30, 2026.

Second Quarter Results and Recent Highlights:


 ●
Net sales were $2.0 million in the second quarter, a 14% increase compared with the prior-year period; U.S. revenue increased 17%

●
Net sales for the first six months of 2026 were $4.4 million, a 20% increase compared with the prior-year period; U.S. revenue increased 24%

●
Gross margin in the second quarter improved to 76%, compared with 56% in the prior-year quarter, reflecting improved pricing, product mix, and the transition to contract manufacturing

●
Sold nine consoles during the second quarter and 24 during the first half of 2026, compared with five during the first half of 2025, expanding the installed base for future circuit utilization

●
First-half revenue increased across all core customer categories compared with the prior-year period, led by a 29% increase in pediatrics, 28% in critical care, and 27% in heart failure. U.S. revenue growth outpaced the total Company average, which included lower international, service, and rental revenue.

●
Raised $6.0 million in gross proceeds through a June registered direct offering

●
Subsequent to June 30, 2026, raised approximately $6.7 million in gross proceeds from a July financing and warrant exercises, strengthening the Company’s cash position and simplifying its capitalization structure

●
Advanced the proposed Aquadex label expansion to patients weighing 5 kilograms or more, from patients weighing 20 kilograms or more, following a successful U.S. Food and Drug Administration pre-submission meeting

●
Appointed Mike McCormick as President and Chief Executive Officer, effective June 30, 2026
 
The second quarter demonstrated continued year-over-year growth, meaningful gross-margin improvement and progress across Nuwellis’ commercial and strategic priorities. The Company enters its next phase focused on increasing the installed based and utilization of Aquadex, building recurring circuit revenue, expanding its position in pediatrics and critical care, and selectively advancing technologies that strengthen its broader cardiorenal platform.

 
 

“Nuwellis has an established commercial foundation with differentiated strength in pediatrics and momentum in critical care. Our straightforward objective is to grow recurring revenue, improve operating leverage, and position Nuwellis as the leading precision fluid management company across the cardiorenal continuum,” said Mike McCormick, Nuwellis President and Chief Executive Officer. “The recent infusion of capital strengthens our balance sheet and extends our cash runway, which provides financial flexibility to execute on our strategic priorities. We intend to concentrate our investments where we have clear clinical differentiation, attractive commercial opportunities, and the ability to generate sustainable shareholder value.  As part of our strategic plan, we are evaluating opportunities to leverage our commercial infrastructure through complementary products and collaborations that deepen relationships within our existing hospital customers.”
 
Second Quarter 2026 Financial Results

Revenue for the second quarter of 2026 was $2.0 million, compared with approximately $1.7 million in the prior-year quarter, representing a 14% increase. The increase was driven by higher U.S. circuit and console sales, partially offset by lower technical services, catheter, and international sales.
 
The Company sold nine consoles during the second quarter, compared with three during the second quarter of 2025. The expanding installed base is expected to bolster growth in recurring circuit revenue, which remains the Company's primary driver of long-term growth.
 
U.S. circuit and console average selling prices increased approximately 5% and 3%, respectively, compared with the prior-year quarter, reflecting pricing adjustments implemented during the third quarter of 2025.
 
Gross margin for the second quarter of 2026 was 76%, compared with 56% in the prior-year quarter.  The improvement reflected pricing adjustments implemented in 2025, favorable product mix, and our successful transition to contract manufacturing.
 
Operating expenses were approximately $4.7 million for the second quarter of 2026, compared with $3.9 million in the prior-year period, reflecting planned investments in commercial expansion and product development. Net loss was approximately $4.8 million, including approximately $1.7 million of non-cash warrant valuation expense associated with the June 2026 financing, compared with a net loss of $12.6 million in the prior-year quarter. Following the effective date of the Company’s most recent reverse stock split on July 2, 2026, the related warrants were reclassified from liability to equity in early July.
 
As of June 30, 2026, the Company had cash and cash equivalents of approximately $3.9 million. Through second-quarter financing activity and subsequent financing events, Nuwellis raised approximately $12.7 million in gross proceeds, strengthening its cash position and simplifying its capitalization structure. This activity included $6.0 million raised in June and, subsequent to June 30, an additional $3.4 million from a July financing and $3.3 million from warrant exercise proceeds.

Webcast and Conference Call Information
 
The Company will host a conference call and webcast at 9:00 a.m. Eastern time today to discuss its financial results and provide an update on the Company’s performance.
 
To access the live webcast, please visit the Investors page of the Nuwellis website at https://ir.nuwellis.com/.
 
Alternatively, the live conference call may be accessed by dialing (833) 316-1983 or (785) 838-9310 and using conference ID NUWEQ2. An audio archive of the webcast will be available following the call on the Investors page.
 
 

About Aquadex
 
The Aquadex SmartFlow System is indicated for the continuous ultrafiltration therapy 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 kilograms 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 of whom having received training in extracorporeal therapies.
 
About Nuwellis
 
Nuwellis, Inc. (Nasdaq: NUWE) is a medical technology company committed to delivering solutions for patients with cardiorenal conditions. The Company develops solutions designed to support patient care through monitoring, therapy, and data-informed clinical decision-making across acute and chronic care settings. Nuwellis’ portfolio includes commercially available and development-stage technologies addressing complex cardiorenal conditions, with a focus on safety, precision, and scalability across patient populations. For more information, visit www.nuwellis.com.
 
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 2026 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:
CORE IR
[email protected]

Media Contact:
CORE PR
[email protected]

 
 

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

   
June 30,
2026
    
December 31,
2025
  
ASSETS
  
(Unaudited)
        
Current assets
            
Cash and cash equivalents
  
$
3,922
    
$
1,085
  
Accounts receivable
    
1,545
      
1,493
  
Inventories, net
    
1,742
      
1,910
  
Other current assets
    
690
      
698
  
Total current assets
    
7,899
      
5,186
  
Property, plant and equipment, net
    
347
      
368
  
Operating lease right-of-use asset
    
179
      
293
  
Intangible assets, net
    
102
      
—
  
Other assets
    
599
      
271
  
TOTAL ASSETS
  
$
9,126
    
$
6,118
  
 
                
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)
                
Current liabilities
                
Accounts payable and accrued liabilities
  
$
2,896
    
$
2,226
  
Accrued compensation
    
731
      
460
  
Current portion of operating lease liability
    
200
      
261
  
Deferred consideration from Rendiatech acquisition, current
    
113
      
—
  
Other current liabilities
    
68
      
85
  
Total current liabilities
    
4,008
      
3,032
  
Deferred consideration from Rendiatech acquisition, non-current
    
200
      
—
  
Warrant liabilities
    
6,963
      
389
  
Operating lease liability
    
—
      
67
  
Total liabilities
    
11,171
      
3,488
  
Commitments and contingencies
                
 
                
Mezzanine Equity
Series J Convertible Preferred Stock as of June 30, 2026 and December 31, 2025, par value $0.0001 per share; authorized 600,000 shares, issued and outstanding 159 and 137, respectively
    
10
      
6
  
                 
Stockholders’ equity (deficit)
                
Series A junior participating preferred stock as of June 30, 2026 and December 31, 2025, par value $0.0001 per share; authorized 30,000 shares, none outstanding
    
—
      
—
  
Series F convertible preferred stock as of June 30, 2026 and December 31, 2025, 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, 2026 and December 31, 2025, par value $0.0001 per share; authorized 100 shares, issued and outstanding 34 and 34 shares, respectively
    
—
      
—
  
Preferred stock as of June 30, 2026 and December 31, 2025, par value $0.0001 per share; authorized 39,352,000 shares, none outstanding
    
—
      
—
  
Common stock as of June 30, 2026 and December 31, 2025, par value $0.0001 per share; authorized 100,000,000 shares, issued and outstanding 574,455 and 48,178, respectively
    
—
      
—
  
Additional paid‑in capital
    
323,618
      
318,928
  
Accumulated other comprehensive income:
                
Foreign currency translation adjustment
    
8
      
8
  
Accumulated deficit
    
(325,681
)
    
(316,312
)
Total stockholders’ equity (deficit)
    
(2,055
)
    
2,624
  
TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)
  
$
9,126
    
$
6,118
  


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

 
  
Three months ended
June 30
    
Six months ended
June 30
  
 
  
2026
    
2025
    
2026
    
2025
  
Net sales
  
$
1,969
    
$
1,725
    
$
4,372
    
$
3,629
  
Cost of goods sold
    
471
      
767
      
1,190
      
1,604
  
Gross profit
    
1,498
      
958
      
3,182
      
2,025
  
Operating expenses:
                                
Selling, general and administrative
    
3,725
      
3,189
      
8,249
      
6,766
  
Research and development
    
942
      
675
      
2,670
      
1,225
  
Total operating expenses
    
4,667
      
3,864
      
10,919
      
7,991
  
Loss from operations
    
(3,169
)
    
(2,906
)
    
(7,737
)
    
(5,966
)
Other income
    
7
      
10
      
8
      
17
  
Financing expense
    
(6,077
)
    
(10,553
)
    
(6,077
)
    
(10,553
)
Change in fair value of warrant liabilities
    
4,411
      
900
      
4,437
      
940
  
Loss before income taxes
    
(4,828
)
    
(12,549
)
    
(9,369
)
    
(15,562
  
Income tax expense
    
-
      
(4
)
    
-
      
(5
)
Net loss
  
$
(4,828
)
  
$
(12,553
)
  
$
(9,369
)
  
$
(15,567
  
Deemed dividend attributable to Series J Convertible Preferred Stock
    
1
      
1
      
3
      
2
  
Net loss attributable to common shareholders
  
$
(4,827
)
  
$
(12,552
)
  
$
(9,366
)
  
$
(15,565
)
 
                                
Basic and diluted loss per share
  
$
(26.64
)
  
$
(2,134.19
)
  
$
(77.90
)
  
$
(3,514.87
)
 
                                
Weighted average shares outstanding – basic and diluted
    
181,243
      
5,881
      
120,263
      
4,428
  
 
                                
Other comprehensive loss:
                                
Net Loss
  
$
(4,828
)
  
$
(12,553
)
  
$
(9,369
)
  
$
(15,567
)
Foreign currency translation adjustments
    
-
      
(5
)
    
-
      
(7
)
Total comprehensive loss
  
$
(4,828
)
  
$
(12,558
)
  
$
(9,369
)
  
$
(15,574
  

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

   
Six Months ended
June 30
  
   
2026
    
2025
  
Operating Activities:
            
Net loss
  
$
(9,369
)
  
$
(15,567
)
Adjustments to reconcile net loss to cash flows used in operating activities:
                
Depreciation and amortization
    
75
      
123
  
Stock-based compensation expense
    
47
      
84
  
Change in fair value of warrant liabilities
    
(4,437
)
    
(940
)
Financing expense
    
6,077
      
10,553
  
Non-cash IP R&D from Rendiatech acquisition
    
757
      
-
  
Changes in operating assets and liabilities:
                
Accounts receivable
    
(52
)
    
534
  
Inventory, net
    
218
      
(310
)
Other current assets
    
8
      
(430
)
Other assets
    
(213
)
    
106
  
Other liabilities
    
(144
)
    
(74
)
Accounts payable and accrued expenses
    
746
      
1,288
  
Net cash used in operating activities
    
(6,287
)
    
(4,633
)
 
                
Investing Activities:
                
Purchases of property and equipment
    
(39
)
    
(4
)
Purchase of intangible assets
    
(90
)
    
-
  
Cash paid for acquisition of Rendiatech, net of cash acquired
    
(164
)
    
-
  
Net cash used in investing activities
    
(293
)
    
(4
)
 
                
Financing Activities:
                
Proceeds from issuance of common stock and warrants, net
    
9,363
      
3,999
  
Issuance of common stock from ATM, net
    
55
      
-
  
Net cash provided by financing activities
    
9,418
      
3,999
  
 
                
Effect of exchange rate changes on cash
    
-
      
(7
)
Net increase (decrease) in cash and cash equivalents
    
2,838
      
(645
)
Cash and cash equivalents, and restricted cash - beginning of period
    
1,190
      
5,095
  
Cash and cash equivalents, and restricted cash - end of period
  
$
4,028
    
$
4,450
  
                 

Supplemental cash flow information
Common stock issued as consideration in asset acquisition
  
$
162
    
$
-
  
Issuance of common stock for conversion of Series F-1 Preferred Stock
  
$
-
    
$
1,100
  
Deferred costs issued as consideration in asset acquisition
  
$
313
    
$
-
  
Deemed dividend on Series J Preferred Stock
  
$
3
    
$
2