Form 8-K

8-K — Nuwellis, Inc.

Accession: 0001140361-26-032838

Filed: 2026-08-13

Period: 2026-08-13

CIK: 0001506492

SIC: 3845 (ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — ef20080204_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (ef20080204_ex99-1.htm)

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8-K

8-K (Primary)

Filename: ef20080204_8k.htm · Sequence: 1

false0001506492NASDAQ00015064922026-08-132026-08-13

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

99.1

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

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: ef20080204_ex99-1.htm · Sequence: 2

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

ir@nuwellis.com

Media Contact:

CORE PR

media@nuwellis.com

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

Total current liabilities

4,008

3,032

Deferred consideration from Rendiatech acquisition, non-current

200

—

Warrant liabilities

6,963

389

Operating lease liability

—

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

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

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

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

)

Net loss

(4,828

)

(12,553

)

(9,369

)

(15,567

Deemed dividend attributable to Series J Convertible Preferred Stock

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

)

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

123

Stock-based compensation expense

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

(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

)

Purchase of intangible assets

(90

)

Cash paid for acquisition of Rendiatech, net of cash acquired

(164

)

Net cash used in investing activities

(293

)

Financing Activities:

Proceeds from issuance of common stock and warrants, net

9,363

3,999

Issuance of common stock from ATM, net

Net cash provided by financing activities

9,418

3,999

Effect of exchange rate changes on cash

)

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

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Document and Entity Information

Aug. 13, 2026

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration