Form 8-K
8-K — Nuwellis, Inc.
Accession: 0001140361-26-020805
Filed: 2026-05-12
Period: 2026-05-12
CIK: 0001506492
SIC: 3845 (ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS)
Item: Results of Operations and Financial Condition
Item: Financial Statements and Exhibits
Documents
8-K — ef20073181_8k.htm (Primary)
EX-99.1 — EXHIBIT 99.1 (ef20073181_ex99-1.htm)
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8-K
8-K (Primary)
Filename: ef20073181_8k.htm · Sequence: 1
false0001506492NASDAQ00015064922026-05-122026-05-12
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 12, 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 May 12, 2026, Nuwellis, Inc. (the “Company”) issued a press release reporting its financial results for the three months ended March 31, 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 May 12, 2026, reporting the financial results of Nuwellis, Inc. for the three months ended March 31, 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: May 12, 2026
NUWELLIS, INC.
By:
/s/ John L. Erb
Name:
John L. Erb
Title:
President, Chief Executive Officer
EX-99.1 — EXHIBIT 99.1
EX-99.1
Filename: ef20073181_ex99-1.htm · Sequence: 2
Exhibit 99.1
Nuwellis, Inc. Announces First Quarter 2026 Financial Results
MINNEAPOLIS – May 12, 2026 – Nuwellis, Inc.
(Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardiorenal conditions, today reported financial results for the first
quarter ended March 31, 2026.
First Quarter and Recent Highlights:
•
Net sales were $2.4 million, a 26% increase compared to the prior-year period
•
Gross margin improved to 70.1%, reflecting improved pricing, product mix, and the transition to contract manufacturing
•
Completed the acquisition of Rendiatech, adding automated kidney-function monitoring capabilities to the Company’s product development portfolio
•
Appointed Carisa Schultz as Chief Financial Officer and Dr. Stuart L. Goldstein as Director of Clinical Strategy
•
Appointed Martin J. Emerson and reappointed David A. McDonald to the Board of Directors
•
Expanded commercial coverage with a new South Texas territory and the return of experienced sales leaders with deep Aquadex expertise
•
Received issuance of a new U.S. patent supporting advanced safety design for pediatric extracorporeal therapy
•
Received a Notice of Allowance from the U.S. Patent and Trademark Office for a new patent covering the Company’s novel dual-lumen midline catheter technology designed for use in ultrafiltration
therapies
The first quarter marked an important step in Nuwellis’ transition from strategic reset to execution. The quarter demonstrated progress across the Company’s
commercial, financial, and platform priorities, with stronger Aquadex performance, continued pediatric momentum, and further expansion of its broader cardiorenal strategy.
“Q1 showed that the strategic reset we made in 2025 is beginning to translate into a more focused and commercially disciplined company,” said John Erb, Chairman and
Chief Executive Officer of Nuwellis. “We are concentrating our resources around the areas where Nuwellis has clear clinical relevance, existing customer traction, and a differentiated path to growth, while maintaining the financial discipline
required to execute. Aquadex gives us the foundation, pediatrics gives us a distinct growth category, and Rendiatech expands our ability to think more broadly across the cardiorenal continuum.”
First Quarter 2026 Financial Results
Revenue for the first quarter of 2026 was $2.4 million, compared to $1.9 million in the prior-year quarter, a 26% increase over the prior year period. Revenue growth
in the first quarter was driven by continued expansion across all core categories, including Pediatric, Adult Heart Failure, and Critical Care, along with growth in both system placements and utilization of Aquadex therapy.
Gross margin for the first quarter of 2026 was 70.1%, a 14% increase to the prior-year quarter. The gross margin improvement reflects improved pricing and product mix
and switching to contract manufacturing.
Operating expenses for the first quarter of 2026 were approximately $6.0 million, compared to approximately $4.1 million in the prior-year quarter. The increase is
driven by increased sales headcount and compensation associated with increased sales.
Net loss attributable to common shareholders for the first quarter of 2026 was approximately $4.3 million.
On March 31, 2026, the Company had no debt and cash, cash equivalents, and restricted cash of approximately $2.2 million.
Webcast and Conference Call Information
The Company will host a conference call and webcast at 9:00 AM ET 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, you may access the live conference call by dialing 1-800-274-8461 (U.S.) or 1-203-518-9814 (international) and using the conference ID: NUWEQ1. An
audio archive of the webcast will be available following the call on the Investors page.
For more information, visit www.nuwellis.com.
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:
Media Contact:
ir@nuwellis.com
CORE PR
media@nuwellis.com
NUWELLIS, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
March 31,
2026
December 31, 2025
ASSETS
(Unaudited)
Current assets
Cash and cash equivalents
$
2,083
$
1,085
Accounts receivable
1,559
1,493
Inventories, net
1,779
1,910
Other current assets
406
698
Total current assets
5,827
5,186
Property, plant and equipment, net
365
368
Operating lease right-of-use asset
237
293
Intangible assets, net
317
—
Other assets
420
271
TOTAL ASSETS
$
7,166
$
6,118
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable and accrued liabilities
$
2,429
$
2,226
Accrued compensation
852
460
Current portion of operating lease liability
265
261
Deferred consideration from Rendiatech acquisition, current
113
—
Other current liabilities
71
85
Total current liabilities
3,730
3,032
Deferred consideration from Rendiatech acquisition, non-current
200
—
Warrant liabilities
362
389
Operating lease liability
—
67
Total liabilities
4,292
3,488
Commitments and contingencies
Mezzanine Equity
Series J Convertible Preferred Stock as of March 31, 2026 and December 31, 2025, par value $0.0001 per share; authorized
600,000 shares, issued and outstanding 147 and 137, respectively
8
6
Stockholders’ equity
Series A junior participating preferred stock as of March 31, 2026 and December 31, 2025, par value $0.0001 per share;
authorized 30,000 shares, none outstanding
—
—
Series F convertible preferred stock as of March 31, 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 March 31, 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 March 31, 2026 and December 31, 2025, par value $0.0001 per share;
authorized 39,352,000 shares, none outstanding
—
—
Common stock as of March 31, 2026 and December 31, 2025, par value $0.0001 per share; authorized 100,000,000 shares, issued
and outstanding 2,635,718 and 1,686,217, respectively
—
—
Additional paid‑in capital
323,508
318,928
Accumulated other comprehensive income:
Foreign currency translation adjustment
8
8
Accumulated deficit
(320,650
)
(316,312
)
Total stockholders’ equity
2,866
2,624
TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY
$
7,166
$
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
March 31
2026
2025
Net sales
$
2,403
$
1,904
Cost of goods sold
719
837
Gross profit
1,684
1,067
Operating expenses:
Selling, general and administrative
4,525
3,577
Research and development
1,524
550
Total operating expenses
6,049
4,127
Loss from operations
(4,365
)
(3,060
)
Other income
1
7
Change in fair value of warrant liabilities
26
40
Loss before income taxes
(4,338
)
(3,013
)
Income tax expense
-
(1
)
Net loss
$
(4,338
)
$
(3,014
)
Deemed dividend attributable to Series J Convertible Preferred Stock
2
1
Net loss attributable to common shareholders
$
(4,336
)
$
(3,013
)
Basic and diluted loss per share
$
(2.09
)
$
(28.98
)
Weighted average shares outstanding – basic and diluted
2,074,940
104,142
Other comprehensive loss:
Net loss
$
(4,338
)
$
(3,014
)
Foreign currency translation adjustments
$
-
$
(2
)
Total comprehensive loss
$
(4,338
)
$
(3,016
)
NUWELLIS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(in thousands)
Three months ended
March 31
2026
2025
Operating Activities:
Net loss
$
(4,338
)
$
(3,014
)
Adjustments to reconcile net loss to cash flows used in operating activities:
Depreciation and amortization
38
73
Stock-based compensation expense
25
67
Change in fair value of warrant liabilities
(26
)
(40
)
Non-cash IP R&D from Rendiatech acquisition
552
-
Changes in operating assets and liabilities:
Accounts receivable
(66
)
187
Inventory, net
181
(34
)
Other current assets
293
41
Other assets
Other liabilities
(171
)
45
Accounts payable and accrued expenses
400
139
Net cash used in operating activities
(3,112
)
(2,536
)
Investing Activities:
Purchases of property and equipment
(30
)
-
Purchase of intangible assets
(90
)
Cash paid for acquisition of Rendiatech, net of cash acquired
(164
)
-
Net cash used in investing activities
(284
)
-
Financing Activities:
Issuance of common stock and warrants from offering, net
4,393
-
Non-cash Series J deemed dividend
2
-
Net cash provided by financing activities
4,395
-
Effect of exchange rate changes on cash
-
(2
)
Net increase (decrease) in cash and cash equivalents
999
(2,538
)
Cash and cash equivalents, and restricted cash - beginning of period
1,190
5,095
Cash and cash equivalents, and restricted cash - end of period
$
2,189
$
2,557
Supplemental cash flow information
Common stock issued as consideration in asset acquisition
$
162
$
-
Transaction costs in accounts payable
$
164
$
-
Deemed dividend on Series J Preferred Stock
$
2
$
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Document and Entity Information
May 12, 2026
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