Nuwellis Reports Third Quarter 2026 Financial Results and Business Update Highlighted by 430 Basis Point Gross Margin Expansion and 13% Reduction in Operating Expenses, Driving 24% Improvement in Operating Loss
Sentiment and the balance of points
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Rhea-AI Summary
Nuwellis (Nasdaq: NUWE) narrowed its third-quarter 2026 operating loss by 24% as higher gross margins and lower operating expenses offset flat sales. Revenue was $2.212 million versus $2.217 million a year earlier, when sales included $0.4 million of accumulated backorders. Gross margin rose to 69.5% from 65.2%, and operating expenses fell 13% to $3.591 million. Net loss was $1.969 million, versus $468,000 net income.
Nine-month revenue rose 13% to $6.584 million, but operating cash use increased to $9.272 million from $7.780 million. Cash totaled $8.290 million at September 30. Console sales reached 32 units year-to-date versus 17, although quarterly sales fell to eight from 12. Nuwellis submitted an FDA application to expand Aquadex use to pediatric patients weighing five kilograms and above. It also signed distribution agreements for Atrility Medical’s AtriAmp and the pediatric Zorro-Flow system.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Major pointJuly financing raised $3.4 million gross through a direct offering and $3.3 million gross through warrant exercises.
- Moderate pointThird-quarter operating loss narrowed 24% to $2.053 million from $2.697 million a year earlier.
- Moderate pointThird-quarter gross margin expanded 430 basis points to 69.5% from 65.2% a year earlier.
- Moderate pointThird-quarter operating expenses declined 13% to $3.591 million from $4.142 million a year earlier.
- Moderate pointNine-month net sales increased 13% to $6.584 million from $5.846 million a year earlier.
- Moderate pointNine-month net loss narrowed to $11.338 million from $15.099 million a year earlier.
- Moderate pointCash and cash equivalents rose to $8.290 million at September 30, 2026, from $1.085 million at year-end.
- Moderate pointThird-quarter common-share sales under the market-sale program raised $1.4 million in net proceeds. 62% of market cap
9 minor points
- Minor pointThird-quarter net sales increased approximately 12% sequentially.
- Minor pointPediatric net sales increased 20% in the quarter and 26% year-to-date versus prior-year periods.
- Minor pointNine-month console sales increased 88% to 32 units from 17 a year earlier.
- Minor pointNine-month gross margin improved to 71.7% from 59.4% a year earlier.
- Minor pointNine-month financing expense decreased to $6.138 million from $10.553 million a year earlier.
- Minor pointAquadex FDA application submitted to expand use to pediatric patients weighing five kilograms and above.
- Minor pointAtrility Medical agreement adds AtriAmp co-promotion and distribution through Nuwellis’ existing sales force.
- Minor pointZorro-Flow agreement grants exclusive U.S. distribution rights for its pediatric external urine collection system.
- Minor pointAquadex pediatric registry study accepted for publication in Pediatric Nephrology.
Negative
- Major pointCommon shares outstanding increased to 540,912 at September 30, 2026, from 5,342 at year-end, diluting existing holders.
- Moderate pointThird-quarter net loss was $1.969 million, versus $468,000 net income, which included a noncash warrant-valuation gain.
- Moderate pointNine-month operating cash use increased to $9.272 million from $7.780 million a year earlier.
- Moderate pointRendiatech acquisition required $164,000 cash, net of cash acquired, and $162,000 in common-stock consideration.
- Minor pointThird-quarter console sales fell to eight units from 12 a year earlier.
4 minor points
- Minor pointNine-month operating loss widened to $9.790 million from $8.663 million a year earlier.
- Minor pointNine-month operating expenses increased to $14.510 million from $12.133 million a year earlier.
- Minor point. Forward-looking: it has not happened yet and may not happen.Aquadex pediatric label expansion remains subject to FDA clearance.
- Minor pointRendiatech acquisition deferred consideration totaled $313,000, including $113,000 current and $200,000 non-current.
News Explained
In July, Nuwellis raised
Key Figures
- Third-quarter net sales
- $2.2 million
- Third quarter 2026; essentially unchanged year over year
- Nine-month net sales
- $6.6 million, up 13%
- Nine months ended September 30, 2026, versus $5.8 million in the prior-year period
- Operating loss
- $2.1 million, improved 24%
- Third quarter 2026 versus the prior-year quarter
- Gross margin
- 69.5%
- Third quarter 2026, versus 65.2% in the prior-year quarter
- Operating expenses
- $3.6 million, down 13%
- Third quarter 2026 versus the prior-year quarter
- Aquadex consoles sold
- 32 consoles, up 88%
- First nine months of 2026 versus 17 consoles in the prior-year period
- Cash and cash equivalents
- $8.3 million
- As of September 30, 2026
- Proposed pediatric indication
- 5 kilograms and above
- Aquadex 510(k) submission sought label expansion
Previous Earnings Reports
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Revenue and gross margin improved, while operating expenses rose and net loss narrowed.
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Quarterly revenue declined year over year as operating expenses and operating loss increased.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
510(k) regulatory
premarket notification regulatory
warrant liabilities financial
AI-generated analysis. How Rhea-AI works. Not financial advice.
Console unit sales increased
Advanced growth strategy with 510(k) submission for Aquadex label expansion and two product portfolio-expanding agreements leveraging existing sales force
Company to conduct conference call beginning at 9:00 a.m. Eastern time today
MINNEAPOLIS, Nov. 12, 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 three and nine months ended September 30, 2026.
Third Quarter 2026 Financial Highlights
- Operating loss for the third quarter of 2026 improved
24% year over year to$2.1 million , driven by 430 basis points of gross margin expansion and a13% reduction in operating expenses, primarily reflecting outsourced manufacturing efficiencies and efforts to align expenses with the highest-priority commercial and strategic programs. - Net sales were
$2.2 million in the third quarter of 2026, essentially unchanged versus the prior-year quarter, as the prior-year period benefited from fulfilling$0.4 million in accumulated backorders. Net sales increased12% sequentially in the third quarter of 2026. For the nine months ended September 30, 2026, net sales increased13% to$6.6 million compared with$5.8 million in the prior-year period, driven by growth in U.S. circuit and console sales. - Pediatrics remained a significant growth driver, with net sales increasing
20% in the third quarter of 2026 and26% year-to-date, compared with the prior-year periods. - Sold 32 Aquadex consoles in the first nine months of 2026, an
88% increase compared with 17 consoles in the prior-year period. The expanded installed base provides a strong foundation for future recurring circuit revenue. - Third-quarter 2026 gross margin expanded to
69.5% from65.2% in the prior-year quarter, reflecting higher average selling prices and continued benefits from the Company's contract manufacturing model. Year-to-date gross margin improved to71.7% , compared with59.4% in the prior-year period. - Strengthened the Company's balance sheet as of September 30, 2026, with
$8.3 million in cash and cash equivalents.
Business Updates
- Submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) seeking to expand the indication of its Aquadex SmartFlow® System to include pediatric patients weighing five kilograms and above.
- A multicenter study titled “Kidney Support in Infants and Children using Aquadex: Findings From the ULTRA-Peds Registry” was accepted for publication in Pediatric Nephrology.
- Entered into a co-promotion and distribution agreement with Atrility Medical for its AtriAmp postoperative cardiac rhythm monitoring device, which leverages Nuwellis’ current pediatric and critical care sales force.
- Secured a second strategic distribution agreement with the exclusive U.S. distribution rights for the pediatric Zorro-Flow™ external urine collection system.
"We have made meaningful progress in strengthening Nuwellis both commercially and financially. Year to date, console unit sales have nearly doubled, expanding our installed base and creating a larger opportunity to grow recurring circuit revenue. Although our third quarter faced a tough comparison against the prior-year period when we fulfilled a significant backorder, the underlying momentum in our business remains strong, as evidenced by the growth in our pediatric segment," said Mike McCormick, Nuwellis President and Chief Executive. "Further, by expanding gross margins and maintaining disciplined cost management, we significantly narrowed our operating loss and cash use during the quarter while continuing to invest in the areas that matter most to our long-term growth.
"We also delivered on several key strategic initiatives, including the submission of a 510(k) to the FDA to expand the Aquadex label to pediatric patients weighing as little as five kilograms, which, if cleared, could expand access and increase adoption. In addition, we secured distribution agreements with Atrility Medical and Zorro-Flow, which broaden our product offering in a capital-efficient manner through our established commercial infrastructure. We believe these achievements position Nuwellis for sustainable growth and long-term value creation for patients, customers and shareholders.”
Third Quarter 2026 Financial Results
Net sales for the third quarter of 2026 were
The Company sold eight Aquadex consoles during the third quarter, compared with 12 in the prior-year quarter. Through the first nine months of 2026, the Company sold 32 consoles, compared with 17 during the comparable 2025 period.
Gross margin for the third quarter of 2026 was
Operating expenses decreased to
In the third quarter of 2026, loss from operations improved
As of September 30, 2026, the Company had cash and cash equivalents of approximately
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 third-quarter 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) 309-3473 or (785) 838-9251 and using conference ID NUWEQ3. 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) | ||||||
| September 30, | December 31, 2025 | |||||
| 2026 | ||||||
| ASSETS | (Unaudited) | |||||
| Current assets | ||||||
| Cash and cash equivalents | $ | 8,290 | $ | 1,085 | ||
| Accounts receivable | 1,391 | 1,493 | ||||
| Inventories, net | 1,770 | 1,910 | ||||
| Other current assets | 479 | 698 | ||||
| Total current assets | 11,930 | 5,186 | ||||
| Property, plant and equipment, net | 303 | 368 | ||||
| Operating lease right-of-use asset | 120 | 293 | ||||
| Intangible assets, net | 93 | — | ||||
| Other assets | 999 | 271 | ||||
| TOTAL ASSETS | $ | 13,445 | $ | 6,118 | ||
| LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY | ||||||
| Current liabilities | ||||||
| Accounts payable and accrued liabilities | $ | 1,986 | $ | 2,226 | ||
| Accrued compensation | 700 | 460 | ||||
| Current portion of operating lease liability | 135 | 261 | ||||
| Deferred consideration from Rendiatech acquisition, current | 113 | — | ||||
| Other current liabilities | 56 | 85 | ||||
| Total current liabilities | 2,990 | 3,032 | ||||
| Deferred consideration from Rendiatech acquisition, non-current | 200 | — | ||||
| Warrant liabilities | 399 | 389 | ||||
| Operating lease liability | 0 | 67 | ||||
| Total liabilities | 3,589 | 3,488 | ||||
| Commitments and contingencies | ||||||
| Mezzanine Equity | ||||||
| Series J Convertible Preferred Stock as of September 30, 2026 and December 31, 2025, par value | 11 | 6 | ||||
| Stockholders’ equity | ||||||
| Series A junior participating preferred stock as of September 30, 2026 and December 31, 2025, par value | — | — | ||||
| Series F convertible preferred stock as of September 30, 2026 and December 31, 2025, par value | — | — | ||||
| Series F-1 convertible preferred stock as of September 30, 2026 and December 31, 2025, par value | — | — | ||||
| Preferred stock as of September 30, 2026 and December 31, 2025, par value | — | — | ||||
| Common stock as of September 30, 2026 and December 31, 2025, par value | — | — | ||||
| Additional paid-in capital | 337,487 | 318,928 | ||||
| Accumulated other comprehensive income: | ||||||
| Foreign currency translation adjustment | 8 | 8 | ||||
| Accumulated deficit | (327,650 | ) | (316,312 | ) | ||
| Total stockholders’ equity | 9,845 | 2,624 | ||||
| TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY | $ | 13,445 | $ | 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 | Nine months ended | |||||||||||||||||||
| September 30, | September 30, | |||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||||||
| Net sales | $ | 2,212 | $ | 2,217 | $ | 6,584 | $ | 5,846 | ||||||||||||
| Cost of goods sold | 674 | 772 | 1,864 | 2,376 | ||||||||||||||||
| Gross profit | 1,538 | 1,445 | 4,720 | 3,470 | ||||||||||||||||
| Operating expenses: | ||||||||||||||||||||
| Selling, general and administrative | 3,007 | 3,539 | 11,256 | 10,305 | ||||||||||||||||
| Research and development | 584 | 603 | 3,254 | 1,828 | ||||||||||||||||
| Total operating expenses | 3,591 | 4,142 | 14,510 | 12,133 | ||||||||||||||||
| Loss from operations | (2,053 | ) | (2,697 | ) | (9,790 | ) | (8,663 | ) | ||||||||||||
| Other income | 51 | 4 | 59 | 21 | ||||||||||||||||
| Financing expense | (61 | ) | - | (6,138 | ) | (10,553 | ) | |||||||||||||
| Change in fair value of warrant liabilities | 94 | 3,161 | 4,531 | 4,101 | ||||||||||||||||
| (Loss) income before income taxes | (1,969 | ) | 468 | (11,338 | ) | (15,094 | ) | |||||||||||||
| Income tax expense | - | - | - | (5 | ) | |||||||||||||||
| Net (loss) income | $ | (1,969 | ) | $ | 468 | $ | (11,338 | ) | $ | (15,099 | ) | |||||||||
| Deemed dividend attributable to Series J Convertible Preferred Stock | 2 | 1 | 5 | 3 | ||||||||||||||||
| Net (loss) income attributable to common shareholders | $ | (1,967 | ) | $ | 469 | $ | (11,333 | ) | $ | (15,096 | ) | |||||||||
| Basic and diluted (loss) income per share | $ | (5.81 | ) | $ | 177.16 | $ | ( 93.13 | ) | $ | (12,548.83 | ) | |||||||||
| Weighted average shares outstanding – basic and diluted | 338,384 | 2,646 | 121,695 | 1,203 | ||||||||||||||||
| Other comprehensive loss: | ||||||||||||||||||||
| Net (loss) income | $ | (1,969 | ) | 468 | (11,338 | ) | (15,099 | ) | ||||||||||||
| Foreign currency translation adjustments | - | (1 | ) | - | (7 | ) | ||||||||||||||
| Total comprehensive (loss) income | $ | (1,969 | ) | $ | 467 | $ | (11,338 | ) | $ | (15,106 | ) | |||||||||
| NUWELLIS, INC. AND SUBSIDIARIES Condensed Consolidated Statements of Cash Flows (Unaudited) (in thousands) | |||||||
| Nine Months ended | |||||||
| September 30, | |||||||
| 2026 | 2025 | ||||||
| Operating Activities: | |||||||
| Net loss | $ | (11,338 | ) | $ | (15,099 | ) | |
| Adjustments to reconcile net loss to cash flows used in operating activities: | |||||||
| Depreciation and amortization | 107 | 166 | |||||
| Stock-based compensation expense | 55 | 103 | |||||
| Change in fair value of warrant liabilities | (4,531 | ) | (4,101 | ) | |||
| Financing expense | 6,138 | 10,553 | |||||
| Non-cash IP R&D from Rendiatech acquisition | 757 | - | |||||
| Changes in operating assets and liabilities: | |||||||
| Accounts receivable | 102 | 586 | |||||
| Inventory, net | 190 | (471 | ) | ||||
| Other current assets | 219 | (461 | ) | ||||
| Other assets | (554 | ) | 108 | ||||
| Other liabilities | (221 | ) | (74 | ) | |||
| Accounts payable and accrued expenses | (196 | ) | 910 | ||||
| Net cash used in operating activities | (9,272 | ) | (7,780 | ) | |||
| Investing Activities: | |||||||
| Purchases of property and equipment | (17 | ) | (102 | ) | |||
| Purchase of intangible assets | (90 | ) | - | ||||
| Cash paid for acquisition of Rendiatech, net of cash acquired | (164 | ) | - | ||||
| Net cash used in investing activities | (271 | ) | (102 | ) | |||
| Financing Activities: | |||||||
| Proceeds from issuance of common stock and warrants, net | 15,392 | 3,999 | |||||
| Issuance of common stock from ATM, net | 1,358 | 1,889 | |||||
| Net cash provided by financing activities | 16,750 | 5,888 | |||||
| Effect of exchange rate changes on cash | — | (7 | ) | ||||
| Net increase (decrease) in cash and cash equivalents | 7,207 | (2,001 | ) | ||||
| Cash and cash equivalents, and restricted cash - beginning of period | 1,190 | 5,095 | |||||
| Cash and cash equivalents, and restricted cash - end of period | $ | 8,397 | $ | 3,094 | |||
| Cash and cash equivalents – end of period | 8,290 | 3,094 | |||||
| Restricted cash – end of period | 107 | -- | |||||
| Cash and cash equivalents, and restricted cash – end of period | $ | 8,397 | $ | 3,094 | |||
| Supplemental cash flow information | ||||||||||||
| Series C warrant conversion to equity | $ | 5,031 | $ | - | ||||||||
| Series D warrant exercises | $ | 1,438 | $ | - | ||||||||
| Deferred costs issued as consideration in asset acquisition | $ | 313 | $ | - | ||||||||
| Common stock issued as consideration in asset acquisition | $ | 162 | $ | - | ||||||||
| Series A warrants conversion to equity | $ | - | $ | 8,439 | ||||||||
| Series B warrant exercises | $ | - | $ | 2,055 | ||||||||
| Issuance of common stock for conversion of Series F-1 Preferred Stock | $ | - | $ | 1,100 | ||||||||
| Deemed dividend on Series J Preferred Stock | $ | 5 | $ | 3 | ||||||||
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What were Nuwellis’ third-quarter 2026 financial results?
Nuwellis reported $2.212 million in net sales and a $1.969 million net loss for the third quarter of 2026. Sales compared with $2.217 million a year earlier, while the operating loss narrowed 24% to $2.053 million. Gross margin increased to 69.5% from 65.2%.
What pediatric label expansion is Nuwellis seeking for Aquadex?
Nuwellis submitted a 510(k) premarket notification, an FDA clearance application, seeking to include pediatric patients weighing five kilograms and above. Aquadex is currently indicated for adults and pediatric patients weighing 20 kilograms or more whose fluid overload does not respond to medical management, including diuretics.