05/15/2026 | Press release | Distributed by Public on 05/15/2026 14:04
| Delaware | No. 68-0533453 | |
| (State or Other Jurisdiction of Incorporation or Organization) | (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) |
|
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
|
|
Large accelerated filer ☐
|
Accelerated filer ☐
|
|||
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Non-accelerated filer ☒
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Smaller reporting company ☒
|
|||
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Emerging growth company ☐
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| Page Number | ||
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PART I-FINANCIAL INFORMATION
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||
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Item 1
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Financial Statements
|
3
|
|
Condensed Consolidated Balance Sheets
|
3
|
|
|
Condensed Consolidated Statements of Operations and Comprehensive Loss
|
4
|
|
|
Condensed Consolidated Statements of Stockholders' Equity
|
5
|
|
|
Condensed Consolidated Statements of Cash Flows
|
6
|
|
|
Notes to Condensed Consolidated Financial Statements
|
7
|
|
|
Item 2
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Management's Discussion and Analysis of Financial Condition and Results of Operations
|
15
|
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Item 3
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Quantitative and Qualitative Disclosures About Market Risk
|
17
|
|
Item 4
|
Controls and Procedures
|
18
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PART II-OTHER INFORMATION
|
||
|
Item 1
|
Legal Proceedings
|
18
|
|
Item 1A
|
Risk Factors
|
18
|
|
Item 2
|
Unregistered Sales of Equity Securities and Use of Proceeds
|
19
|
|
Item 3
|
Defaults Upon Senior Securities
|
19
|
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Item 4
|
Mine Safety Disclosures
|
19
|
|
Item 5
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Other Information
|
19
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|
Item 6
|
Exhibits
|
19
|
|
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
|
112 | - | ||||||
|
Other assets
|
420 | 271 | ||||||
|
TOTAL ASSETS
|
$ | 6,961 | $ | 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
|
323,506 | 318,928 | ||||||
|
Accumulated other comprehensive income:
|
||||||||
|
Foreign currency translation adjustment
|
8 | 8 | ||||||
|
Accumulated deficit
|
(320,853 | ) | (316,312 | ) | ||||
|
Total stockholders' equity
|
2,661 | 2,624 | ||||||
|
TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY
|
$ | 6,961 | $ | 6,118 | ||||
|
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
|
4,524 | 3,577 | ||||||
|
Research and development
|
1,728 | 550 | ||||||
|
Total operating expenses
|
6,252 | 4,127 | ||||||
|
Loss from operations
|
(4,568 | ) | (3,060 | ) | ||||
|
Other income
|
1 | 7 | ||||||
|
Change in fair value of warrant liabilities
|
26 | 40 | ||||||
|
Loss before income taxes
|
(4,541 | ) | (3,013 | ) | ||||
|
Income tax expense
|
- | (1 | ) | |||||
|
Net loss
|
$ | (4,541 | ) | $ | (3,014 | ) | ||
|
Deemed dividend attributable to Series J Convertible Preferred Stock
|
2 | 1 | ||||||
|
Net loss attributable to common shareholders
|
$ | (4,539 | ) | $ | (3,013 | ) | ||
|
Basic and diluted loss per share
|
$ | (2.19 | ) | $ | (28.93 | ) | ||
|
Weighted average shares outstanding - basic and diluted
|
2,074,940 | 104,142 | ||||||
|
Other comprehensive loss:
|
||||||||
|
Net loss
|
$ | (4,541 | ) | $ | (3,014 | ) | ||
|
Foreign currency translation adjustments
|
$ | - | $ | (2 | ) | |||
|
Total comprehensive loss
|
$ | (4,541 | ) | $ | (3,016 | ) | ||
|
Outstanding Shares of Common Stock |
Common Stock |
Additional Paid in Capital |
Accumulated Other Comprehensive Income |
Accumulated Deficit |
Stockholders' Equity |
|||||||||||||||||||
|
Balance December 31, 2024
|
104,142 | $ | - | $ | 305,366 | $ | (47 | ) | $ | (298,791 | ) | $ | 6,528 | |||||||||||
|
Net loss
|
- | - | - | - | (3,014 | ) | (3,014 | ) | ||||||||||||||||
|
Unrealized foreign currency translation adjustment
|
- | - | - | (2 | ) | - | (2 | ) | ||||||||||||||||
|
Stock-based compensation
|
- | - | 67 | - | - | 67 | ||||||||||||||||||
|
Series J convertible preferred stock deemed dividend
|
- | - | (1 | ) | - | - | (1 | ) | ||||||||||||||||
|
Balance March 31, 2025
|
104,142 | $ | - | $ | 305,432 | $ | (49 | ) | $ | (301,805 | ) | $ | 3,578 | |||||||||||
|
Outstanding Shares of Common Stock |
Common Stock |
Additional Paid in Capital |
Accumulated Other Comprehensive Income |
Accumulated Deficit |
Stockholders' Equity |
|||||||||||||||||||
|
Balance December 31, 2025
|
1,686,217 | $ | - | $ | 318,928 | $ | 8 | $ | (316,312 | ) | $ | 2,624 | ||||||||||||
|
Net loss
|
- | - | - | - | (4,541 | ) | (4,541 | ) | ||||||||||||||||
|
Issuance of common stock from exercise of warrants
|
799,501 | - | 4,393 | - | - | 4,393 | ||||||||||||||||||
|
Issuance of common stock from Rendiatech acquisition
|
150,000 | - | 162 | - | - | 162 | ||||||||||||||||||
|
Stock-based compensation
|
- | - | 25 | - | - | 25 | ||||||||||||||||||
|
Series J convertible preferred stock deemed dividend
|
- | - | (2 | ) | - | - | (2 | ) | ||||||||||||||||
|
Balance March 31, 2026
|
2,635,718 | $ | - | $ | 323,506 | $ | 8 | $ | (320,853 | ) | $ | 2,661 | ||||||||||||
|
|
Three months ended March 31 |
|||||||
| 2026 | 2025 | |||||||
|
Operating Activities:
|
||||||||
|
Net loss
|
$ | (4,541 | ) | $ | (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
|
757 | - | ||||||
|
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
|
398 | 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 | $ | - | ||||
| Deferred costs issued as consideration in asset acquisition | $ | 313 | $ | - | ||||
|
Deemed dividend on Series J Preferred Stock
|
$ | 2 | $ | 1 | ||||
|
(in thousands)
|
March 31,
2026 |
December 31,
2025 |
||||||
| Finished Goods | $ | 285 | $ | 445 | ||||
|
Work in Process
|
138 | 88 | ||||||
|
Raw Materials
|
1,449 | 1,457 | ||||||
|
Inventory Reserves
|
(93 | ) | (80 | ) | ||||
|
Total
|
$ | 1,779 | $ | 1,910 | ||||
|
March 31
|
||||||||
|
2026
|
2025
|
|||||||
|
Stock options
|
34,446 | 81 | ||||||
|
Warrants to purchase common stock
|
4,815,296 | 126,787 | ||||||
|
Series F convertible preferred stock
|
10,719 | 1,642 | ||||||
| Series F-1 convertible preferred stock | 13,498 | - | ||||||
|
Series J convertible preferred stock
|
87 | 2 | ||||||
|
Total
|
4,874,046 | 128,512 | ||||||
|
Three months ended March 31 |
||||||||
| 2026 | 2025 | |||||||
| (in thousands, except per share amounts) | ||||||||
|
Net loss
|
$ | (4,541 | ) | $ | (3,014 | ) | ||
|
Deemed dividend attributable to Series J Convertible Preferred Stock
|
2 | 1 | ||||||
|
Net loss attributable to common shareholders
|
$ | (4,539 | ) | $ | (3,013 | ) | ||
|
Weighted average shares outstanding
|
2,075 | 104 | ||||||
|
Basic and diluted loss per share
|
$ | (2.19 | ) | $ | (28.93 | ) | ||
|
Warrant Type
|
Shares Underlying
|
Exercise Price
|
Fair Value
|
Expiration Date
|
Status
|
|||||||||
|
Pre-Funded Warrants
|
819,296 | $ | 0.0001 | $ | 4.19 |
Upon full exercise
|
Outstanding
|
|||||||
|
Private Placement Common Warrants
|
1,989,074 | $ | 2.84 | $ | 3.887 |
January 30, 2031
|
Outstanding
|
|||||||
|
Inducement Warrants
|
1,247,170 | $ | 2.84 | $ | 3.887 |
5 years from resale registration effective date
|
Outstanding
|
|||||||
|
Agent Warrants
|
48,544 | $ | 5.0985 | $ | 3.779 |
January 29, 2031
|
Outstanding
|
|
Three months ended March 31 |
||||||||
|
(in thousands)
|
|
2026 | 2025 | |||||
|
Selling, general and administrative expense
|
$ | 24 | $ | 65 | ||||
|
Research and development expense
|
1 | 2 | ||||||
|
Total stock-based compensation expense
|
$ | 25 | $ | 67 | ||||
|
(in thousands)
|
March 31, 2026 |
December 31, 2025 |
||||||
|
Warrant liability Series B
|
$ | 6 | $ | 12 | ||||
|
Warrant liability Series J
|
355 | 377 | ||||||
|
Deferred consideration liability (Rendiatech)
|
313 | - | ||||||
|
Total Level 3 liabilities
|
$ | 674 | $ | 389 | ||||
|
(in thousands)
|
Warrant Liabilities |
Deferred Consideration |
Total | |||||||||
|
Balance at December 31, 2025
|
$ | 389 | $ | - | $ | 389 | ||||||
|
Acquisition of Rendiatech (initial fair value)
|
- | 313 | 313 | |||||||||
|
Exercise of Series B warrants
|
(2 | ) | - | (2 | ) | |||||||
|
Change in fair value
|
(26 | ) | - | (26 | ) | |||||||
|
Balance at March 31, 2026
|
$ | 361 | $ | 313 | $ | 674 | ||||||
|
|
Three months ended
March 31
|
|||||||
|
2026
|
2025
|
|||||||
|
Revenue
|
$ | 2,403 | $ | 1,904 | ||||
|
Gross Profit
|
1,684 | 1,067 | ||||||
|
Gross profit %
|
70.1 | % | 56.0 | % | ||||
|
Operating expenses:
|
||||||||
|
General and administrative
|
2,371 | 1,846 | ||||||
|
Sales and marketing
|
2,084 | 1,430 | ||||||
|
Development
|
1,397 | 206 | ||||||
|
Clinical, Quality, Regulatory
|
400 | 578 | ||||||
|
Total operating expenses
|
6,252 | 4,060 | ||||||
|
Stock Based Compensation
|
- | 67 | ||||||
|
Other income (expense)
|
(27 | ) | (46 | ) | ||||
|
Net income (loss)
|
$ | (4,541 | ) | $ | (3,014 | ) | ||
|
Description
|
Amount | |||
|
Cash paid at closing
|
$ | 149 | ||
|
Less: Cash acquired
|
(24 | ) | ||
|
Net cash consideration
|
125 | |||
|
Fair value of common stock issued (150,000 shares)
|
162 | |||
|
Transaction costs capitalized
|
203 | |||
|
Additional cash payments
|
313 | |||
|
Total consideration transferred
|
$ | 803 | ||
|
Description
|
Fair Value | |||
|
Inventory
|
$ | 50 | ||
|
In-process R&D
|
757 | |||
|
Non-compete agreements
|
27 | |||
|
Liabilities assumed
|
(31 | ) | ||
|
Net assets acquired
|
$ | 803 | ||
|
Three months ended
March 31, 2026 |
Three months ended
March 31, 2025 |
Increase (Decrease)
|
% Change
|
|||||||
|
$
|
2,403
|
$
|
1,904
|
$
|
499
|
26.2
|
%
|
|||
|
(in thousands)
|
Three months ended
March 31, 2026
|
Three months ended
March 31, 2025
|
Increase (Decrease)
|
% Change
|
||||||||||||
|
Cost of goods sold
|
$ | 719 | $ | 837 | $ | (118 | ) | (14.1 | )% | |||||||
|
Selling, general and administrative
|
$ | 4,524 | $ | 3,577 | $ | 947 | 26.5 | % | ||||||||
|
Research and development
|
$ | 1,728 | $ | 550 | $ | 1,178 | 214.4 | % | ||||||||
|
Incorporated By Reference
|
||||||||||||||
|
Exhibit
Number
|
Exhibit Description
|
Form
|
File
Number
|
Date of First Filing
|
Exhibit
Number
|
Filed
Herewith
|
Furnished
Herewith |
|||||||
| 3.1 | Fourth Amended and Restated Certificate of Incorporation | 10 | 001-35312 | February 1, 2012 | 3.1 | |||||||||
| 3.2 | Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation | 8-K | 001-35312 | January 13, 2017 | 3.1 | |||||||||
| 3.3 | Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation | 8-K | 001-35312 | May 23, 2017 | 3.1 | |||||||||
| 3.4 | Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation | 8-K | 001-35312 | October 12, 2017 | 3.1 | |||||||||
|
Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation
|
8-K
|
001-35312
|
January 2, 2019
|
3.1
|
||||||||||
| 3.6 | Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation | 8-K/A | 001-35312 | October 16, 2020 | 3.1 | |||||||||
|
Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation
|
8-K
|
001-35312
|
April 27, 2021
|
3.1
|
||||||||||
|
Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation
|
8-K
|
001-35312
|
December 9, 2022
|
3.1
|
||||||||||
|
Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation
|
8-K
|
001-35312
|
June 26, 2024
|
3.1
|
||||||||||
|
Certificate of Amendment to Fourth Amended and Restated Certificate of Incorporation, as amended, of Nuwellis, Inc.
|
8-K
|
001-35312
|
July 2, 2025
|
3.1
|
||||||||||
|
Third Amended and Restated Bylaws
|
10-Q
|
000-35312
|
November 12, 2024
|
3.13
|
||||||||||
|
Amendment to Third Amended and Restated Bylaws
|
10-Q
|
001-35312
|
November 12, 2024
|
3.14
|
||||||||||
| 3.13 | Form of Certificate of Designation of Preferences, Rights and Limitations of Series F Convertible Preferred Stock | S-1/A | 333-221010 | November 17, 2017 | 3.7 | |||||||||
|
Incorporated By Reference
|
||||||||||||||
|
Exhibit
Number
|
Exhibit Description | Form |
File
Number
|
Date of First Filing |
Exhibit
Number
|
Filed
Herewith
|
Furnished Herewith |
|||||||
|
Certificate of Designation of Preferences, Rights and Limitations of Series I Convertible Preferred Stock
|
8-K
|
001-35312
|
October 18, 2022
|
3.1
|
||||||||||
|
Certificate of Designations of Preferences, Rights and Limitations of Series F-1 Convertible Preferred Stock
|
8-K
|
001-35312
|
June 9, 2025
|
3.1
|
||||||||||
|
Form of Common Stock Purchase Warrant
|
8-K
|
001-35312
|
January 30, 2026
|
4.1
|
||||||||||
|
Form of Pre-Funded Warrant
|
8-K
|
001-35312
|
January 30, 2026
|
4.2
|
||||||||||
|
Form of January Inducement Warrant
|
8-K
|
001-35312
|
January 30, 2026
|
4.3
|
||||||||||
|
Form of Securities Purchase Agreement, dated as of January 29, 2026, by and among the Company and the Purchaser identified on the signature page thereto
|
8-K
|
001-35312
|
January 30, 2026
|
10.1
|
||||||||||
|
Placement Agency Agreement, dated as of January 29, 2026, by and between the Company and the Placement Agent
|
8-K
|
001-35312
|
January 30, 2026
|
10.2
|
||||||||||
|
Form of Registration Rights Agreement, dated as of January 29, 2026, by and among the Company and the Purchaser identified on the signature page thereto.
|
8-K
|
001-35312
|
January 30, 2026
|
10.3
|
||||||||||
|
Form of Warrant Inducement Offer Letter
|
8-K
|
001-35312
|
January 30, 2026
|
10.4
|
||||||||||
|
Securities Purchase Agreement, dated January 29, 2026, by and among the Company, Rendiatech and the sellers named therein.
|
8-K
|
001-35312
|
January 30, 2026
|
10.5
|
||||||||||
|
Offer Letter, by and between Nuwellis, Inc. and Carisa Schultz, effective February 2, 2026
|
8-K
|
001-35312
|
January 30, 2026
|
10.6
|
||||||||||
| 31.1 | Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | X | ||||||||||||
| 31.2 | Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | X | ||||||||||||
| 32.1 | Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | X | ||||||||||||
| 32.2 | Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | X | ||||||||||||
| 101.INS | Inline XBRL Instance Document | X | ||||||||||||
| 101.SCH | Inline XBRL Taxonomy Extension Schema Document | X | ||||||||||||
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101.CAL
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Inline XBRL Taxonomy Extension Calculation Linkbase Document
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X | ||||||||||||
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101.DEF
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Inline XBRL Taxonomy Extension Definition Linkbase Document
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X | ||||||||||||
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101.LAB
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Inline XBRL Taxonomy Extension Label Linkbase Document
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X | ||||||||||||
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101.PRE
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Inline XBRL Taxonomy Extension Presentation Linkbase Document
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X | ||||||||||||
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) | X | ||||||||||||
| Nuwellis, Inc. | |||
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Date: May 15, 2026
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By:
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/s/ John L. Erb
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John L. Erb
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President, Chief Executive Officer
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