MINNEAPOLIS, March 10, 2026 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardiorenal conditions, today reported financial results for the fourth quarter and full year ended December 31, 2025.
Fourth Quarter and Recent Highlights:
- Fourth quarter revenue of $2.4 million, a 4% increase compared to the prior-year quarter and 9% increase sequentially.
- 208% increase in U.S. console sales in Q4 versus prior year quarter.
- Heart Failure revenue increased 48% and Pediatrics increased 16% year-over-year in Q4.
- Gross margin of 68.2% in Q4, compared to 58.4% in the prior-year quarter.
- Closed a $5.0 million private placement and warrant inducement transaction in January 2026, strengthening the Company's capital position.
- Appointed Carisa Schultz as Chief Financial Officer, effective February 2, 2026.
- Executed a definitive stock purchase agreement to acquire Rendiatech, expanding the Company's cardiorenal portfolio.
"2025 was a year of structural change and strategic re-focus for Nuwellis," said John Erb, Chief Executive Officer of Nuwellis. "While full year revenue declined compared to 2024, fourth quarter results reflected stronger utilization trends and meaningful gross margin expansion. Throughout the year, we prioritized operational discipline, refined our commercial focus around the cardiorenal continuum, and strengthened the underlying foundation of the business."
"Additionally, we are entering 2026 with new momentum," Mr. Erb added, "including the execution of our agreement to acquire Rendiatech and the pending expansion of our portfolio, the appointment of a new Chief Financial Officer, and additional capital to support operations. As we look ahead, we remain focused on integrating the Rendiatech acquisition, progressing development of Vivian, our novel pediatric solution supported by NIH grant funding, and driving more consistent commercial execution and deeper utilization within targeted accounts."
Fourth Quarter 2025 Financial Results
Revenue for the fourth quarter of 2025 was $2.4 million, a 4% increase compared to the prior-year quarter and a 9% increase sequentially. The year-over-year increase was attributable to a 208% increase in U.S. console sales (8 units vs. 3), an 11% circuit average selling price increase, and a non-recurring 59% increase in international sales, reflecting customer last-time buys. Growth in Heart Failure and Pediatrics was partially offset by lower Critical Care revenue compared to the prior-year quarter.
Gross margin for the fourth quarter of 2025 was 68.2%, compared to 58.4% in the prior-year quarter. The gross margin improvement reflects improved pricing and product mix, partially offset by unfavorable manufacturing variances.
Operating expenses for the fourth quarter of 2025 were approximately $4.1 million, compared to approximately $3.7 million in the prior-year quarter.
Operating loss for the fourth quarter of 2025 was approximately $2.4 million, flat with the prior-year quarter.
Net loss attributable to common shareholders for the fourth quarter of 2025 was approximately $2.4 million.
Full Year 2025 Financial Results
Revenue for the full year ended December 31, 2025, was $8.3 million, a 5% decrease compared to the prior year. Heart Failure revenue increased 8% year-over-year, and Pediatrics increased 14%, while Critical Care declined 19%.
Gross margin as a percent of revenue for the full year was 62.0%, compared to 64.9% in the prior year.
Operating expenses for the full year were $16.2 million, $0.4 million lower than the prior year.
Net loss attributable to common shareholders for the full year was $17.5 million, which includes a $6.4 million non-cash warrant valuation expense and approximately $0.3 million in executive severance expense.
On December 31, 2025, the Company had no debt and cash, cash equivalents and restricted cash of approximately $1.2 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 1-800-343-4885 (U.S.) or 1-203-518-9851 (international) and using the conference ID: NUWEQ4. 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 advancing precision fluid management technologies across the cardiorenal continuum. 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.
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.
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:
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) | |||||||
| December 31, 2025 | December 31, 2024 | ||||||
| ASSETS | |||||||
| Current assets | |||||||
| Cash and cash equivalents | - | 1,085 | - | 5,095 | |||
| Accounts receivable | 1,493 | 1,727 | |||||
| Inventories, net | 1,910 | 1,718 | |||||
| Other current assets | 698 | 315 | |||||
| Total current assets | 5,186 | 8,855 | |||||
| Property, plant and equipment, net | 368 | 478 | |||||
| Operating lease right-of-use asset | 293 | 510 | |||||
| Other assets | 271 | 21 | |||||
| TOTAL ASSETS | - | 6,118 | - | 9,864 | |||
| LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY | |||||||
| Current liabilities | |||||||
| Accounts payable and accrued liabilities | - | 2,226 | - | 1,640 | |||
| Accrued compensation | 460 | 640 | |||||
| Current portion of operating lease liability | 261 | 238 | |||||
| Other current liabilities | 85 | 41 | |||||
| Total current liabilities | 3,032 | 2,559 | |||||
| Warrant liabilities | 389 | 468 | |||||
| Operating lease liability | 67 | 307 | |||||
| Total liabilities | 3,488 | 3,334 | |||||
| Commitments and contingencies | |||||||
| Mezzanine Equity Series J Convertible Preferred Stock as of December 31, 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 December 31, 2025 and December 31, 2024, par value $0.0001 per share; authorized 30,000 shares, none outstanding | - | - | |||||
| Series F convertible preferred stock as of December 31, 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 December 31, 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 December 31, 2025 and December 31, 2024, par value $0.0001 per share; authorized 39,352,000 shares, none outstanding | - | - | |||||
| Common stock as of December 31, 2025 and December 31, 2024, par value $0.0001 per share; authorized 100,000,000 shares, issued and outstanding 1,686,217 and 104,142, respectively | - | - | |||||
| Additional paid-in capital | 318,928 | 305,366 | |||||
| Accumulated other comprehensive income: | |||||||
| Foreign currency translation adjustment | 8 | (47 | - | ||||
| Accumulated deficit | (316,312 | - | (298,791 | - | |||
| Total stockholders' equity | 2,624 | 6,528 | |||||
| TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY | - | 6,118 | - | 9,864 | |||
| NUWELLIS, INC. AND SUBSIDIARY Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except per share amounts and weighted average shares outstanding) | |||||||||||||||
| Three months ended December 31 | Twelve months ended December 31 | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Net sales | - | 2,424 | - | 2,322 | - | 8,270 | - | 8,740 | |||||||
| Cost of goods sold | 770 | 967 | 3,146 | 3,064 | |||||||||||
| Gross profit | 1,654 | 1,355 | 5,124 | 5,676 | |||||||||||
| Operating expenses: | |||||||||||||||
| Selling, general and administrative | 3,213 | 2,911 | 13,518 | 13,455 | |||||||||||
| Research and development | 884 | 831 | 2,712 | 3,209 | |||||||||||
| Total operating expenses | 4,097 | 3,742 | 16,230 | 16,664 | |||||||||||
| Loss from operations | (2,443 | - | (2,387 | - | (11,106 | - | (10,988 | - | |||||||
| Other income (expense), net | (11 | - | 7 | 10 | (80 | - | |||||||||
| Gain on settlement | - | 900 | - | 900 | |||||||||||
| Financing expense | - | - | (10,553 | - | (5,607 | - | |||||||||
| Change in fair value of warrant liabilities | 32 | 13 | 4,133 | 4,615 | |||||||||||
| Income (loss) before income taxes | (2,422 | - | (1,467 | - | (17,516 | - | (11,160 | - | |||||||
| Income tax expense | - | (1 | - | (5 | - | (5 | - | ||||||||
| Net income (loss) | - | (2,422 | - | - | (1,468 | - | - | (17,521 | - | - | (11,165 | - | |||
| Deemed dividend attributable to Series J Convertible Preferred Stock | 1 | - | 4 | 541 | |||||||||||
| Net income (loss) attributable to common shareholders | - | (2,421 | - | - | (1,468 | - | - | (17,517 | - | - | (10,624 | - | |||
| Basic and diluted income (loss) per share | - | (1.50 | - | - | (18.30 | - | - | (25.39 | - | - | (353.30 | - | |||
| Weighted average shares outstanding - basic and diluted | 1,614,214 | 80,015 | 690,145 | 31,601 | |||||||||||
| Other comprehensive loss: | |||||||||||||||
| Net income (loss) | - | (2,422 | - | - | (1,468 | - | - | (17,521 | - | - | (11,165 | - | |||
| Foreign currency translation adjustments | - | 62 | - | (1 | - | - | 55 | - | (16 | - | |||||
| Total comprehensive income (loss) | - | (2,360 | - | - | (1,469 | - | - | (17,466 | - | - | (11,181 | - | |||
| NUWELLIS, INC. AND SUBSIDIARY Condensed Consolidated Statements of Cash Flows (in thousands) | |||||||
| Twelve months ended December 31 | |||||||
| 2025 | 2024 | ||||||
| Operating Activities: | |||||||
| Net loss | - | (17,521 | - | - | (11,165 | - | |
| Adjustments to reconcile net loss to cash flows used in operating activities: | |||||||
| Depreciation and amortization | 200 | 310 | |||||
| Stock-based compensation expense | 127 | 478 | |||||
| Change in fair value of warrant liabilities | (4,133 | - | (4,615 | - | |||
| Loss on disposal of intangible asset | - | 99 | |||||
| Financing expense | 10,553 | 5,607 | |||||
| Amortization of operating lease right-of-use asset | 217 | - | |||||
| Changes in operating assets and liabilities: | |||||||
| Accounts receivable | 234 | 224 | |||||
| Inventory, net | (192 | - | 279 | ||||
| Other current assets | (528 | - | (160 | - | |||
| Other assets and liabilities | (173 | - | (22 | - | |||
| Accounts payable and accrued expenses | 406 | (626 | - | ||||
| Net cash used in operating activities | (10,810 | - | (9,591 | - | |||
| Investing Activities: | |||||||
| Purchases of property and equipment | (90 | - | (60 | - | |||
| Net cash used in investing activities | (90 | - | (60 | - | |||
| Financing Activities: | |||||||
| Issuance of common stock and warrants from offering, net | 3,999 | 2,403 | |||||
| Issuance of common stock from ATM, net | 2,941 | - | |||||
| Proceeds from the exercise of Series J Convertible Preferred Warrants | - | 501 | |||||
| Proceeds from the exercise of April 2024 Warrants | - | 2,246 | |||||
| Issuance of July and August 2024 Common Stock and Warrants | - | 2,160 | |||||
| Proceeds from warrant inducement in November 2024, net | - | 3,364 | |||||
| Proceeds from the exercise of warrants, net | - | 288 | |||||
| Net cash provided by financing activities | 6,940 | 10,962 | |||||
| Effect of exchange rate changes on cash | 55 | (16 | - | ||||
| Net decrease in cash, cash equivalents and restricted cash | (3,905 | - | 1,295 | ||||
| Cash, cash equivalents and restricted cash - beginning of period | 5,095 | 3,800 | |||||
| Cash, cash equivalents and restricted cash - end of period | - | 1,190 | - | 5,095 | |||
| Supplemental schedule of non-cash activities | |||||||
| 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 | - | 8,440 | - | - | |||
| 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 | - | 4 | - | 541 | |||
| Supplemental cash flow information | |||||||
| Cash paid for income taxes | - | 7 | - | 7 |
