olivLaw · US equity research
Nuwellis, Inc. NUWE
Electromedical & Electrotherapeutic Apparatus · SIC 3845 · Vertical: Electromedical & Electrotherapeutic Apparatus (SIC 3845)
Nuwellis develops and sells the Aquadex system, an ultrafiltration device used to remove excess fluid in controlled fashion from patients with heart failure, after cardiac surgery, in critical care and in children. The company reports rising sales and a much improved gross margin in 2026, but it still depends on new capital, so its financial trajectory remains uncertain. First-half 2026 net sales were 4.4 million dollars, up 20 percent, and second-quarter gross margin reached 76 percent.
At the close of 04 Nov 2026, Nuwellis, Inc. (NUWE) stock was 5.27 USD (−10.83% on the day), with market capitalisation 19.2 m USD, beta 3.88, 52-week range 0.32–146.65 USD. Latest reported quarter (Q2 2026): revenue of 2.0 m USD (+14.1% YoY), net income of -4.8 m USD, diluted EPS -26.64 USD.
Data as of · AI analysis dated · Source: SEC filings and closing prices, computed by olivLaw.
Price history
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Technical reading
- RSI (14)
- 63.0
- strong (55–70)
- Bollinger (20, 2)
- -2.09 – 7.37
- in the upper half of the band · %B 0.78 · band width 357.9%
- SMA 50 / 200
- 1.55 / 28.11
- mixed trend
- MACD (12, 26, 9)
- 1.27 / 0.88
- MACD above signal
Indicators describe past prices; on their own they do not predict direction. On our history the RSI ≤ 40 filter added no return (see the signals methodology).
Performance
| Company | S&P 500 | vs S&P 500 | Vertical median | |
|---|---|---|---|---|
| 1 month | +663.8% | −1.1% | +664.9 pp | — |
| 3 months | +208.2% | −0.5% | +208.6 pp | — |
| 6 months | −86.2% | +4.4% | −90.6 pp | — |
| Year to date | −91.3% | +12.3% | −103.7 pp | — |
| 1 year | −94.4% | +13.5% | −107.9 pp | −0.4% |
| 3 years | −100.0% | +76.4% | −176.4 pp | −17.4% |
| 5 years | −100.0% | +63.7% | −163.7 pp | — |
Price returns, dividends excluded.
Quarterly results
Latest quarter: Q2 2026 · 30 Jun 2026
Quarterly margins
Quarterly statements · USD
| Fiscal year | Q3 '24 | Q4 '24 | Q1 '25 | Q2 '25 | Q3 '25 | Q4 '25 | Q1 '26 | Q2 '26 |
|---|---|---|---|---|---|---|---|---|
| Revenue | 2.4 m | 2.3 m | 1.9 m | 1.7 m | 2.2 m | 2.4 m | 2.4 m | 2.0 m |
| Cost of revenue | 711.0 k | 967.0 k | 837.0 k | 767.0 k | 772.0 k | 770.0 k | 719.0 k | 471.0 k |
| Gross profit | 1.7 m | 1.4 m | 1.1 m | 958.0 k | 1.4 m | 1.7 m | 1.7 m | 1.5 m |
| Research & development | 486.0 k | 831.0 k | 550.0 k | 675.0 k | 603.0 k | 884.0 k | 1.7 m | 942.0 k |
| SG&A | 2.7 m | 2.9 m | 3.6 m | 3.2 m | 3.5 m | 3.2 m | 4.5 m | 3.7 m |
| Operating income | -1.5 m | -2.4 m | -3.1 m | -2.9 m | -2.7 m | -2.4 m | -4.6 m | -3.2 m |
| Depreciation & amortisation | 76.0 k ≈ | 83.0 k | 73.0 k | 50.0 k ≈ | 43.0 k ≈ | 34.0 k | 38.0 k | 37.0 k ≈ |
| Pre-tax income | 2.4 m | -1.5 m | -3.0 m | -12.5 m | 468.0 k | -2.4 m | -4.5 m | -4.8 m |
| Income tax | 0 | 1.0 k | 1.0 k | 4.0 k | 0 | 0 | 0 | 0 |
| Net income | 2.4 m | -1.5 m | -3.0 m | -12.6 m | 468.0 k | -2.4 m | -4.5 m | -4.8 m |
| Diluted EPS | 73.23 | — | -28.93 | -2,134.19 | 0.56 | -1.51 ≈ | -2.19 | -26.64 |
| Operating cash flow | -2.5 m ≈ | -1.5 m | -2.5 m | -2.1 m ≈ | -3.1 m ≈ | -3.0 m | -3.1 m | -3.2 m ≈ |
| Capex | -16.0 k ≈ | 23.0 k | 0 | 4.0 k ≈ | 98.0 k ≈ | -12.0 k | 30.0 k | 9.0 k ≈ |
≈ derived quarter (cumulative difference / share-days average)
E/P over time
E/P = trailing-12-month diluted EPS / price at quarter end. E/P is the inverse of P/E and stays defined when earnings are negative.
Fiscal years
| Fiscal year | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|---|
| Revenue | 5.0 m | 5.5 m | 7.4 m | 7.9 m | 8.5 m | 8.9 m | 8.7 m | 8.3 m |
| Revenue YoY | +40.7% | +10.3% | +35.0% | +6.5% | +7.9% | +3.8% | −1.4% | −5.4% |
| Net income | -17.0 m | -18.1 m | -15.8 m | -19.6 m | -14.5 m | -20.2 m | -11.2 m | -17.5 m |
| Net income YoY | unavailable | unavailable | unavailable | unavailable | unavailable | unavailable | unavailable | unavailable |
| Diluted EPS | unavailable | unavailable | -10.67 | -285.36 | -83.55 | -360.06 | -353.30 | -25.39 |
| Diluted EPS YoY | unavailable | unavailable | unavailable | unavailable | unavailable | unavailable | unavailable | unavailable |
| net % | -340.8% | -328.7% | -212.8% | -246.9% | -170.0% | -228.0% | -127.7% | -211.9% |
| Free cash flow | -14.8 m | -16.9 m | -16.9 m | -18.1 m | -15.3 m | -18.1 m | -9.7 m | -10.9 m |
Reported results vs expectations
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Balance sheet & financial health
Fiscal year 2025 · 31 Dec 2025
- Cash
- 1.1 m USD
- Financial debt
- unavailable USD
- Net debt
- unavailable USD
- Equity
- 2.6 m USD
- Total assets
- 6.1 m USD
- Debt / equity
- unavailable
- Current ratio
- 1.71x
- ROE
- -382.9%
- ROA
- -219.3%
- FCF margin
- -131.8%
Financial statements (source on every figure)
Revenue and net income (USD)
Margins
Income statement · USD
| Line | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | Source (latest year) |
|---|---|---|---|---|---|---|---|
| Revenue | 7.4 m | 7.9 m | 8.5 m | 8.9 m | 8.7 m | 8.3 m | SEC (XBRL)· 11 Mar 2026verified |
| Cost of revenue | 3.4 m | 3.4 m | 3.8 m | 3.9 m | 3.1 m | 3.1 m | SEC (XBRL)· 11 Mar 2026verified |
| Gross profit | 4.1 m | 4.5 m | 4.8 m | 5.0 m | 5.7 m | 5.1 m | SEC (XBRL)· 11 Mar 2026verified |
| Research & development | 3.7 m | 5.0 m | 4.3 m | 5.4 m | 3.2 m | 2.7 m | SEC (XBRL)· 11 Mar 2026verified |
| SG&A | 17.4 m | 19.0 m | 17.6 m | 17.2 m | 13.5 m | 13.5 m | SEC (XBRL)· 11 Mar 2026verified |
| Operating income | -17.0 m | -19.5 m | -17.2 m | -17.6 m | -11.0 m | -11.1 m | SEC (XBRL)· 11 Mar 2026verified |
| Depreciation & amortisation | 376.0 k | 488.0 k | 372.0 k | 362.0 k | 310.0 k | 200.0 k | SEC (XBRL)· 11 Mar 2026verified |
| EBITDA | -16.7 m ≈ | -19.0 m ≈ | -16.8 m ≈ | -17.3 m ≈ | -10.7 m ≈ | -10.9 m ≈ | SEC (XBRL)· 11 Mar 2026derived |
| Pre-tax income | -15.8 m | -19.5 m | -14.5 m | -20.2 m | -11.2 m | -17.5 m | SEC (XBRL)· 11 Mar 2026verified |
| Income tax | 9.0 k | 9.0 k | 9.0 k | 8.0 k | 5.0 k | 5.0 k | SEC (XBRL)· 11 Mar 2026verified |
| Net income | -15.8 m | -19.6 m | -14.5 m | -20.2 m | -11.2 m | -17.5 m | SEC (XBRL)· 11 Mar 2026verified |
| Diluted EPS | -10.67 | -285.36 | -83.55 | -360.06 | -353.30 | -25.39 | SEC (XBRL)· 11 Mar 2026verified |
| Weighted average diluted shares | 1.6 m | 69.0 k | 173.8 k | 56.1 k | 31.6 k | 690.1 k | SEC (XBRL)· 11 Mar 2026verified |
≈ computed by olivLaw from the reported lines of the same year: Operating income + Depreciation & amortisation.
Balance sheet · USD
| Line | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | Source (latest year) |
|---|---|---|---|---|---|---|---|
| Cash | 14.4 m | 8.7 m | 17.7 m | 3.8 m | 5.1 m | 1.1 m | SEC (XBRL)· 11 Mar 2026verified |
| Receivables | 905.0 k | 750.0 k | 1.4 m | 2.0 m | 1.7 m | 1.5 m | SEC (XBRL)· 11 Mar 2026verified |
| Inventories | 3.0 m | 2.8 m | 2.7 m | 2.0 m | 1.7 m | 1.9 m | SEC (XBRL)· 11 Mar 2026verified |
| Current assets | 18.5 m | 28.1 m | 22.8 m | 8.2 m | 8.9 m | 5.2 m | SEC (XBRL)· 11 Mar 2026verified |
| Property, plant & equipment, net | 1.2 m | 1.2 m | 980.0 k | 728.0 k | 478.0 k | 368.0 k | SEC (XBRL)· 11 Mar 2026verified |
| Intangibles (excl. goodwill) | — | — | — | — | — | 0 | SEC (XBRL)· 15 May 2026verified |
| Total assets | 20.0 m | 30.4 m | 24.7 m | 9.8 m | 9.9 m | 6.1 m | SEC (XBRL)· 11 Mar 2026verified |
| Accounts payable | 1.1 m | 1.4 m | 2.2 m | 2.4 m | 1.6 m | 2.2 m | SEC (XBRL)· 11 Mar 2026verified |
| Current liabilities | 3.6 m | 3.3 m | 4.7 m | 3.2 m | 2.6 m | 3.0 m | SEC (XBRL)· 11 Mar 2026verified |
| Total liabilities | 3.7 m | 4.5 m | 12.3 m | 6.6 m | 3.3 m | 3.5 m | SEC (XBRL)· 11 Mar 2026verified |
| Equity | 16.3 m † | 25.9 m † | 12.4 m † | 3.0 m † | 6.5 m † | 2.6 m † | SEC (XBRL)· 11 Mar 2026verified |
† equity attributable to the parent's shareholders: in these years the issuer no longer reports the total including non-controlling interests.
Cash flow · USD
| Line | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | Source (latest year) |
|---|---|---|---|---|---|---|---|
| Operating cash flow | -16.6 m | -17.8 m | -15.1 m | -17.9 m | -9.6 m | -10.8 m | SEC (XBRL)· 11 Mar 2026verified |
| Capex | 298.0 k | 219.0 k | 122.0 k | 149.0 k | 60.0 k | 90.0 k | SEC (XBRL)· 11 Mar 2026verified |
| Free cash flow | -16.9 m ≈ | -18.1 m ≈ | -15.3 m ≈ | -18.1 m ≈ | -9.7 m ≈ | -10.9 m ≈ | SEC (XBRL)· 11 Mar 2026derived |
| Investing cash flow | -267.0 k | -15.7 m | 14.7 m | 330.0 k | -60.0 k | -90.0 k | SEC (XBRL)· 11 Mar 2026verified |
| Financing cash flow | 30.0 m | 27.9 m | 9.4 m | 3.7 m | 11.0 m | 6.9 m | SEC (XBRL)· 11 Mar 2026verified |
≈ computed by olivLaw from the reported lines of the same year: Operating cash flow − Capex.
Computed indicators
Growth
Profitability
Returns
Balance sheet
Liquidity
Cash
Efficiency
Market and valuation
1 indicators that do not apply to the sector.
Valuation
olivLaw classification
- indicators available: 4 of at least 6
- score weight coverage: 27.1% of at least 60%
- valuation methods computed: 0 of at least 1
A scoring methodology on indicators and valuation, not investment advice.
Closing price
04 Nov 2026Source: olivLaw, closing series
Market cap: 19.2 m USD
Key indicators
Coverage and freshness
Score by group
27% · Insufficient data
Estimated value range
unavailable — no valuation method could be computed
Valuation assumptions are editorial choices, not measured; beta is not measured.
Valuation methods
- DCF (discounted cash flow)unavailable · the reported interest expense is far older than the latest period (the filer changed its XBRL tag): a stale figure is not used
- Peers: EV/EBITDAunavailable · net debt missing: EV cannot be bridged to equity (missing debt is not zero)
- Peers: P/Eunavailable · the base of the ratio is not positive
- Dividend discount (DDM)unavailable · the company pays no dividend: a dividend model needs an explicit initiation assumption
no valuation method could be computed
Classification (SIC) comparables group by industry code, not by economic activity; the direct group is an editorial selection by activity. Members' multiples are on their own trailing twelve months, at their own latest close.
Assumptions (illustrative, editorial)
- Risk-free rate
- 4.3%
- Equity risk premium
- 5.0%
- Beta (default)
- 1.00
- Cost of equity
- 9.3%
- Terminal growth
- 2.5%
Factor scorecard
Insufficient data
Minimum-evidence gate: indicators available: 4 of at least 6; score weight coverage: 27.1% of at least 60%; valuation methods computed: 0 of at least 1
| Factor | Value | Score | Weight used |
|---|---|---|---|
| ROIC · Quality | unavailable | unavailable | — |
| Net margin · Quality | -125.6% | 23 (vs peers) | 23% |
| FCF conversion · Quality | unavailable | unavailable | — |
| Revenue CAGR 3Y · Growth | -1.1% | 0 (on a fixed band) | 31% |
| EPS CAGR 3Y · Growth | unavailable | unavailable | — |
| Net debt / EBITDA · Balance sheet | unavailable | unavailable | — |
| Interest coverage · Balance sheet | unavailable | unavailable | — |
| Current ratio · Balance sheet | 2.0x | 98 (on a fixed band) | 15% |
| P/E (TTM) · Valuation | unavailable | unavailable | — |
| EV/EBITDA · Valuation | unavailable | unavailable | — |
| FCF yield · Valuation | -65.5% | 0 (on a fixed band) | 31% |
| Shareholder yield (distributions) · Returns | unavailable | unavailable | — |
| Payout ratio (FCF) · Returns | unavailable | unavailable | — |
Factors without a value were dropped; the remaining weights were renormalised.
Score groups
- Balance sheet· partial98/100 · 1/3 factors with a value
- Growth· partial0/100 · 1/2 factors with a value
- Quality· partial23/100 · 1/3 factors with a value
- Returns· partialunavailable · 0/2 factors with a value
- Valuation· partial0/100 · 1/3 factors with a value
A «partial» group is computed from under half of its weight or from one factor: it is not a full assessment of the group.
Memo
NUWELLIS, INC. (NUWE). Latest full fiscal year: 2025; data up to 2026-06-30.
Figures computed from the financial statements: revenue 8.3 m USD in 2025; YoY growth -5.4%; net margin -125.6%.
Valuation cannot be computed from the available data.
Insufficient data for a verdict (indicators available: 4 of at least 6; score weight coverage: 27.1% of at least 60%; valuation methods computed: 0 of at least 1).
Text generated deterministically from the figures shown; no language model. Not investment advice.
What supports the thesis
- Current ratio: 2.0x
What contradicts it
- Net margin: -125.6%
- Revenue CAGR 3Y: -1.1%
- FCF yield: -65.5%
Not assessed (insufficient data or a ratio without meaning): ROIC, FCF conversion, EPS CAGR 3Y, Net debt / EBITDA, Interest coverage, P/E (TTM), EV/EBITDA, Shareholder yield (distributions), Payout ratio (FCF).
Versus the vertical median
Electromedical & Electrotherapeutic Apparatus (SIC 3845) · same industry (4-digit SIC) · compared with 24 companies
Multiples and returns vs the median
Price rebased to 100 (monthly, 5 years)
Companies in the vertical
| Market cap | P/E | ROE | Net margin | Revenue YoY | 1A / 3A | |
|---|---|---|---|---|---|---|
| MDTMedtronic plc | 134.3 bn | 25.8 | 10.7% | 13.9% | +8.4% | −0% / +32% |
| LIVNLivaNova PLC | 5.2 bn | 31.3 | 15.5% | 13.0% | +10.7% | +48% / +110% |
| ITGRInteger Holdings Corporation | 4.3 bn | 42.5 | 6.0% | 5.7% | +8.0% | +75% / +45% |
| AXGNAxogen, Inc. | 3.1 bn | — | -10.3% | -12.0% | +20.2% | +79% / +684% |
| TMDXTransMedics Group, Inc. | 2.5 bn | 18.9 | 36.3% | 22.7% | +37.1% | −50% / −4% |
| BLFSBioLife Solutions, Inc. | 1.9 bn | 33.5 | 15.1% | 56.4% | +28.9% | unavailable / unavailable |
| CNMDConmed Corporation | 1.6 bn | 21.8 | 7.1% | 5.4% | +5.2% | +24% / −50% |
| CBLLCeriBell, Inc. | 1.1 bn | — | -52.5% | -68.0% | +36.1% | +61% / unavailable |
| INMDInMode Ltd. | 899.7 m | 9.9 | 13.5% | 25.3% | −6.2% | −0% / −40% |
| CVCapsoVision, Inc | 342.8 m | — | — | -214.7% | +15.3% | +23% / unavailable |
| ELMDElectromed, Inc. | 234.3 m | 21.5 | 23.3% | 15.3% | +15.3% | +5% / +172% |
| FOCLEdap Tms SA | 162.9 m | — | -321.7% | -49.1% | +1.6% | +81% / −17% |
| VANIVivani Medical, Inc. | 96.5 m | — | -220.4% | — | unavailable | −21% / +13% |
| STXSStereotaxis, Inc. | 95.9 m | — | -325.9% | -74.2% | +20.3% | −61% / −42% |
| NRXSNeuraxis, Inc. | 86.1 m | — | -139.8% | -144.4% | +32.9% | +147% / +117% |
| OMOutset Medical, Inc. | 83.8 m | — | -63.0% | -58.3% | +5.1% | −3% / −94% |
| ECORelectroCore, Inc. | 77.5 m | — | — | -33.5% | +27.2% | +66% / +49% |
| POCIPrecision Optics Corporation, Inc. | 53.1 m | — | -22.3% | -11.5% | +65.2% | +3% / −18% |
| NXLNexalin Technology, Inc. | 34.4 m | — | -240.3% | -4,139.4% | +78.8% | −95% / −87% |
| QTIQt Imaging Holdings, Inc. | 32.1 m | — | -2,125.0% | -77.3% | +287.9% | −64% / −99% |
| NUWENuwellis, Inc. | 19.2 m | — | — | -125.6% | −5.4% | −94% / −100% |
| IRIXIridex Corp | 12.6 m | — | -73.1% | -6.9% | unavailable | −26% / −72% |
| NDRAEndra Life Sciences Inc. | 7.4 m | — | -152.0% | — | unavailable | −16% / −100% |
| ITOCiTonic Holdings Ltd | — | — | -82.8% | -974.7% | +16.7% | −80% / unavailable |
| HYPRHyperfine, Inc. | 0 | — | -97.0% | -210.8% | +5.2% | −30% / −41% |
1- and 3-year price returns: for NUWE from daily closes (the same as the performance table), for the other companies from month-end closes.
olivLaw engine forecast
The world engine ran after the company's latest material disclosure. Probabilities are of TOUCHING a level within the horizon (not closing there) and sit next to the random walk (p_rw), the no-information benchmark.
The engine has no published run for this company yet.
Valuation scenarios (editable assumptions)
Illustrative scenarios
Illustrative: not forecasts and without probabilities. Each case is one coherent set of assumptions, computed on today's figures.
Estimated price (USD)
| Estimated price | Bear | Base | Bull |
|---|---|---|---|
| 1 years | insufficient data Total return unavailable · Per year unavailable | insufficient data Total return unavailable · Per year unavailable | insufficient data Total return unavailable · Per year unavailable |
| 3 years | insufficient data Total return unavailable · Per year unavailable | insufficient data Total return unavailable · Per year unavailable | insufficient data Total return unavailable · Per year unavailable |
| 5 years | insufficient data Total return unavailable · Per year unavailable | insufficient data Total return unavailable · Per year unavailable | insufficient data Total return unavailable · Per year unavailable |
AI analysis
AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.
In brief
Nuwellis develops and sells the Aquadex system, an ultrafiltration device used to remove excess fluid in controlled fashion from patients with heart failure, after cardiac surgery, in critical care and in children. The company reports rising sales and a much improved gross margin in 2026, but it still depends on new capital, so its financial trajectory remains uncertain. First-half 2026 net sales were 4.4 million dollars, up 20 percent, and second-quarter gross margin reached 76 percent3.
SWOT
Strengths
- The company has a clinical technology with documented use in thousands of patients and a range of pediatric and critical care indications, plus a gross margin that rose after the move to third-party manufacturing13.
- A direct salesforce in the US and a position in pediatrics give a niche advantage that rivals could find hard to replicate quickly13.
- The device can be prescribed by any trained physician, which could speed hospital adoption1.
Weaknesses
- The company depends on a single product, the Aquadex system, so revenue is exposed to any market or regulatory problem affecting it1.
- Operating losses persist, and the accumulated deficit shows that profitability has not yet been reached2.
- The company has reported weaknesses in internal control over financial reporting, which could undermine confidence in its financial statements1.
Opportunities
- Extending the indication to lower-weight patients could open a neonatal market if authorities approve the change3.
- A growing installed base of consoles could generate recurring circuit revenue over the long term3.
- Recent clinical guidance for cardiac surgery could expand hospital use of ultrafiltration1.
Threats
Risks
- Capital needshigh
The company has said it will need additional financing to fund operations and that without it could be forced to reduce or stop activities13.
- Single-product dependencehigh
Revenue comes almost entirely from the Aquadex system, so any adoption, regulatory or production problem could have a major effect on the company1.
- Customer concentrationmedium
A small number of customers generate a substantial share of sales, and a reduction in orders from one of them could materially affect quarterly revenue1.
- Reliance on third-party manufacturingmedium
Manufacturing is outsourced under contract to a single supplier, and any problem there could delay deliveries to customers1.
- Weak internal controlsmedium
The company has identified material weaknesses in internal control over financial reporting which, if not remediated, could lead to errors or restatements1.
Investment thesis
What would need to be true (bull case)
- If sales keep growing and gross margin stays high, the company could show that its recurring-revenue model is viable3.
- Extending the indication to smaller patients could open a new market with limited competition3.
- Clinical guidance and cost-saving evidence could persuade more hospitals to adopt ultrafiltration1.
What would break the thesis
- The company keeps accumulating losses, and repeated need for capital could dilute existing shareholders12.
- Dependence on a single product and a small number of customers makes revenue fragile if adoption slows1.
- Internal control problems and leadership change could complicate execution of the strategy if not resolved quickly12.
What to watch
- Trend in sales of consumable circuits and installed consolesQ3 2026
- Progress of the request to extend the indication to patients of at least 5 kg2027
- New financings and possible shareholder dilution2027
- Remediation of internal control weaknesses in financial reportingnext 10-K
Products, market & competition
AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.
The business
Nuwellis, Inc. (NUWE, Nasdaq) focuses on developing, manufacturing and commercializing ultrafiltration devices, notably the Aquadex FlexFlow and Aquadex SmartFlow systems, indicated for adult and pediatric patients weighing at least 20 kg whose fluid overload does not respond to medical management, including diuretics1. The company estimates it has treated approximately 15,000 patients since reintroducing the system to the US market in 20161. The product consists of a console, a single-use blood circuit set and a catheter1. Second-quarter 2026 net sales were 2.0 million dollars, up 14 percent3.
The revenue model rests on selling consoles and consumable circuits, the latter being the recurring revenue the company regards as essential to long-term growth3. Operationally, Nuwellis moved production of circuits, catheters and consoles to the outside manufacturer KDI Precision Manufacturing, which helped improve gross margin13. Sales are made mainly in the US through a direct salesforce to hospitals and clinics2.
In 2026 the company went through a leadership change, with its new chief executive taking office on June 30, 2026, and sought to strengthen its balance sheet through several financings23. It ended the REVERSE-HF clinical study and exited some international operations to focus on the US, pediatrics, critical care and outpatient heart failure1.
Segments
Pediatrics
Pediatrics accounted for about 40 percent of company revenue in 2025, and the company estimates the US market for this indication at about 160 million dollars1. Sales growth across customer categories in the first half of 2026 was strongest in pediatrics3.
Market context
The target market is fluid overload, a condition linked to heart failure, kidney disease and cardiac surgery, for which the company estimates US markets of about 160 million dollars in pediatrics and 900 million in critical care1. The company argues ultrafiltration can reduce hospital costs compared with diuretic therapy, citing a saving of 3,975 dollars per patient over 90 days1. These estimates come from the company's own filings and have not been independently verified.
Real market size depends on hospital adoption and reimbursement, and the customer base is concentrated: the ten largest customers represented about 49 percent of revenue in 20251. Extending the indication to patients of at least 5 kg could open a neonatal market if regulators approve it3.
Trends
- Ultrafiltration as an alternative to diureticstailwind
Many heart failure patients respond poorly to diuretics, and this could favour adoption of ultrafiltration if hospitals find the clinical results convincing1.
- Guidelines for cardiac surgerytailwind
Recent guidance on acute kidney injury after cardiac surgery mentions possible use of ultrafiltration in patients unresponsive to diuretics, which could widen use cases1.
- Financing pressure and dilutionheadwind
The company needs additional capital and has issued new shares and warrants, which may reduce value for existing shareholders if financing remains necessary12.
- Pricing and marginsmixed
Pricing adjustments in 2025 and the move to third-party manufacturing contributed to a better gross margin, but the sustainability of that improvement depends on sales volume3.
Competitive position
Competing treatments include traditional loop diuretics and other forms of ultrafiltration, which are usually administered by nephrologists1. The company says its system can be prescribed by any physician, an advantage it considers distinctive1.
The market is fragmented and dominated by standard drug treatment, so Nuwellis's success depends on demonstrating economic and clinical benefits against existing therapies1.
- Loop diuretics and associated drug therapies
Traditional treatment for fluid overload; the sources do not name specific listed producers
- Other ultrafiltration systems
Conventional ultrafiltration, usually administered by nephrologists; suppliers are not identified in the sources reviewed
- Continuous dialysis devices
The company cites them as the alternative technology for very low-weight pediatric patients; suppliers are not named in the source
- Critical care and cardiac care providers
Hospital-level competition for budgets and equipment, with no producers named in the sources provided
Links, dependencies and risks
Who the company is tied to, from its own SEC filings (customers, suppliers, production, partners, competitors, countries, regulation), from the 5 %+ holders' statements (13D/13G) and from what other companies say about it. Click a node for its evidence; on a listed company the graph moves to it.
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News & filings
In the press
No news in our archive over the last 180 days.
SEC filings
- Current report23 Oct 2026Item 3.03 · Amendments to articles or bylaws · Financial statements and exhibits
- Current report26 Aug 2026Regulation FD disclosure · Financial statements and exhibits
- Current report13 Aug 2026Results of operations · Financial statements and exhibits
- Quarterly report13 Aug 2026
- Current report03 Aug 2026Material agreement · Item 3.02 · Other events · Financial statements and exhibits
- Current report24 Jul 2026Shareholder vote
- Proxy statement07 Jul 2026
- Current report24 Jun 2026Item 3.03 · Amendments to articles or bylaws · Financial statements and exhibits
- Current report18 Jun 2026Departure or appointment of officers · Regulation FD disclosure · Financial statements and exhibits
- Current report10 Jun 2026Regulation FD disclosure · Financial statements and exhibits
Sources
- [1] Form 10-K, fiscal year ended 2025-12-31 · SEC / Nuwellis, Inc. · 11 Mar 2026
- [2] Form 10-Q, quarter ended 2026-06-30 · SEC / Nuwellis, Inc. · 13 Aug 2026
- [3] Form 8-K, results release (exhibit 99.1) · SEC / Nuwellis, Inc. · 13 Aug 2026
Figures computed by olivLaw from SEC filings and closing prices; the qualitative analysis is AI-generated from cited sources. Not investment advice.