olivLaw · US equity research
KORU Medical Systems, Inc. KRMD
Surgical & Medical Instruments & Apparatus · SIC 3841 · Vertical: Surgical & Medical Instruments & Apparatus (SIC 3841)
KORU Medical Systems develops, manufactures and sells large-volume subcutaneous infusion systems, used mainly for home delivery of subcutaneous immunoglobulin. The company reported 22.2% revenue growth in fiscal 2025, with net revenues of 41.1 million USD, and updated its 2026 guidance to revenue of 47.5 - 48.5 million USD.
At the close of 04 Nov 2026, KORU Medical Systems, Inc. (KRMD) stock was 3.27 USD (+5.48% on the day), with market capitalisation 151.0 m USD, beta 1.07, 52-week range 2.93–6.52 USD. Latest reported quarter (Q2 2026): revenue of 12.0 m USD (+18.2% YoY), net income of 252.4 k USD, diluted EPS 0.01 USD.
Data as of · AI analysis dated · Source: SEC filings and closing prices, computed by olivLaw.
Price history
Loading chart…
Technical reading
- RSI (14)
- 58.6
- strong (55–70)
- Bollinger (20, 2)
- 2.90 – 3.26
- above the upper band · %B 1.03 · band width 11.6%
- SMA 50 / 200
- 3.13 / 4.01
- mixed trend
- MACD (12, 26, 9)
- 0.01 / -0.01
- 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 | +8.6% | −1.1% | +9.7 pp | — |
| 3 months | −20.8% | −0.5% | −20.4 pp | — |
| 6 months | −18.5% | +4.4% | −22.8 pp | — |
| Year to date | −43.7% | +12.3% | −56.0 pp | — |
| 1 year | −15.3% | +13.5% | −28.8 pp | −3.6% |
| 3 years | +46.6% | +76.4% | −29.8 pp | −16.1% |
| 5 years | +7.2% | +63.7% | −56.5 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 | 8.2 m | 8.8 m | 9.6 m | 10.2 m | 10.4 m | 10.9 m | 11.8 m | 12.0 m |
| Cost of revenue | 3.0 m | 3.3 m | 3.6 m | 3.7 m | 4.1 m | 4.1 m | 4.5 m | 4.2 m |
| Gross profit | 5.2 m | 5.6 m | 6.0 m | 6.5 m | 6.3 m | 6.8 m | 7.2 m | 7.8 m |
| Research & development | 1.5 m | 1.1 m | 1.1 m | 1.2 m | 933.1 k | 1.1 m | 1.3 m | 1.1 m |
| SG&A | 5.1 m | 5.8 m | 6.0 m | 5.4 m | 6.0 m | 6.0 m | 6.6 m | 5.9 m |
| Operating income | -1.7 m | -1.6 m | -1.2 m | -312.7 k | -867.7 k | -547.1 k | -864.9 k | 627.0 k |
| Depreciation & amortisation | 227.8 k | 211.5 k | 217.4 k | 209.5 k | 204.5 k | 179.2 k | 197.5 k | 210.0 k |
| Pre-tax income | -1.6 m | -1.6 m | -1.2 m | -189.5 k | -778.1 k | -482.2 k | -807.1 k | 258.2 k |
| Income tax | — | — | — | 17.4 k | -150 | 4.7 k | — | 5.8 k |
| Net income | -1.6 m | -1.6 m | -1.2 m | -206.9 k | -778.0 k | -486.9 k | -807.1 k | 252.4 k |
| Diluted EPS | 0.03 | -0.03 ≈ | -0.03 | 0.00 | 0.02 | -0.01 ≈ | -0.02 | 0.01 |
| Operating cash flow | -923.9 k ≈ | 939.6 k | -237.5 k | -460.3 k ≈ | 65.5 k ≈ | 1.1 m | 14.7 k | 216.1 k ≈ |
| Capex | 1.1 m ≈ | -43.6 k | 443.4 k | 28.8 k ≈ | 52.5 k ≈ | 407.8 k | 46.2 k | 107.9 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 | 17.4 m | 23.2 m | 24.2 m | 23.5 m | 27.9 m | 28.5 m | 33.6 m | 41.1 m |
| Revenue YoY | — | +33.5% | +4.4% | −2.8% | +18.8% | +2.2% | +18.0% | +22.2% |
| Net income | 910.6 k | 564.3 k | -1.2 m | -4.6 m | -8.7 m | -13.7 m | -6.1 m | -2.6 m |
| Net income YoY | — | −38.0% | −314.8% | unavailable | unavailable | unavailable | unavailable | unavailable |
| Diluted EPS | 0.02 | 0.01 | -0.03 | -0.10 | -0.19 | -0.30 | -0.13 | -0.06 |
| Diluted EPS YoY | — | −50.0% | −400.0% | unavailable | unavailable | unavailable | unavailable | unavailable |
| net % | 5.2% | 2.4% | -5.0% | -19.4% | -31.0% | -48.2% | -18.0% | -6.4% |
| Free cash flow | 1.2 m | 119.4 k | -1.7 m | -4.7 m | -8.2 m | -5.7 m | -1.6 m | -470.1 k |
The series breaks before 2018: earlier years come from the original reports of the issuer of that time, later years from a subsequent filing that restated the perimeter (a separation, discontinued operations). The year-on-year change across the break is not shown.
Reported results vs expectations
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Balance sheet & financial health
Fiscal year 2025 · 31 Dec 2025
- Cash
- 8.9 m USD
- Financial debt
- unavailable USD
- Net debt
- unavailable USD
- Equity
- 17.0 m USD
- Total assets
- 28.2 m USD
- Debt / equity
- unavailable
- Current ratio
- 2.44x
- ROE
- -15.6%
- ROA
- -9.5%
- FCF margin
- -1.1%
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 | 24.2 m | 23.5 m | 27.9 m | 28.5 m | 33.6 m | 41.1 m | SEC (XBRL)· 12 Mar 2026verified |
| Cost of revenue | 9.2 m | 9.7 m | 12.5 m | 11.8 m | 12.3 m | 15.5 m | SEC (XBRL)· 12 Mar 2026verified |
| Gross profit | 14.9 m | 13.8 m | 15.4 m | 16.7 m | 21.3 m | 25.6 m | SEC (XBRL)· 12 Mar 2026verified |
| Research & development | 1.3 m | 2.5 m | 5.0 m | 5.7 m | 5.3 m | 4.4 m | SEC (XBRL)· 12 Mar 2026verified |
| SG&A | 12.0 m | 17.9 m | 20.6 m | 20.4 m | 21.6 m | 23.4 m | SEC (XBRL)· 12 Mar 2026verified |
| Operating income | -1.3 m | -7.0 m | -10.8 m | -10.3 m | -6.4 m | -3.0 m | SEC (XBRL)· 12 Mar 2026verified |
| Depreciation & amortisation | 418.6 k | 463.1 k | 587.1 k | 870.4 k | 888.5 k | 810.5 k | SEC (XBRL)· 12 Mar 2026verified |
| EBITDA | -836.2 k ≈ | -6.6 m ≈ | -10.2 m ≈ | -9.4 m ≈ | -5.6 m ≈ | -2.2 m ≈ | SEC (XBRL)· 12 Mar 2026derived |
| Pre-tax income | 1.2 m | -6.4 m | -10.7 m | -9.8 m | -6.1 m | -2.6 m | SEC (XBRL)· 12 Mar 2026verified |
| Income tax | -17.8 k | -1.8 m | -2.0 m | 4.0 m | 2.9 k | 21.9 k | SEC (XBRL)· 12 Mar 2026verified |
| Net income | -1.2 m | -4.6 m | -8.7 m | -13.7 m | -6.1 m | -2.6 m | SEC (XBRL)· 12 Mar 2026verified |
| Diluted EPS | -0.03 | -0.10 | -0.19 | -0.30 | -0.13 | -0.06 | SEC (XBRL)· 12 Mar 2026verified |
| Weighted average diluted shares | 41.9 m | 44.4 m | 45.0 m | 45.6 m | 45.8 m | 46.2 m | SEC (XBRL)· 12 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 | 27.3 m | 25.3 m | 17.4 m | 11.5 m | 9.6 m | 8.9 m | SEC (XBRL)· 12 Mar 2026verified |
| Receivables | 2.6 m | 3.6 m | 3.6 m | 4.0 m | 5.7 m | 6.2 m | SEC (XBRL)· 12 Mar 2026verified |
| Inventories | 6.8 m | 6.1 m | 6.4 m | 3.5 m | 2.8 m | 3.7 m | SEC (XBRL)· 12 Mar 2026verified |
| Current assets | 37.5 m | 37.3 m | 29.8 m | 20.3 m | 19.1 m | 20.0 m | SEC (XBRL)· 12 Mar 2026verified |
| Property, plant & equipment, net | 1.2 m | 1.1 m | 3.9 m | 3.8 m | 4.3 m | 4.5 m | SEC (XBRL)· 12 Mar 2026verified |
| Intangibles (excl. goodwill) | 843.6 k | 808.8 k | 787.2 k | 754.4 k | 730.3 k | 684.8 k | SEC (XBRL)· 12 Mar 2026verified |
| Total assets | 39.9 m | 41.3 m | 42.3 m | 28.5 m | 27.2 m | 28.2 m | SEC (XBRL)· 12 Mar 2026verified |
| Accounts payable | 624.9 k | 1.2 m | 2.4 m | 975.2 k | 1.6 m | 2.3 m | SEC (XBRL)· 12 Mar 2026verified |
| Current liabilities | 3.7 m | 4.8 m | 7.0 m | 4.5 m | 7.2 m | 8.2 m | SEC (XBRL)· 12 Mar 2026verified |
| Total liabilities | 3.8 m | 4.8 m | 11.0 m | 8.1 m | 10.4 m | 11.2 m | SEC (XBRL)· 12 Mar 2026verified |
| Equity | 36.2 m † | 36.5 m † | 31.3 m † | 20.4 m † | 16.8 m † | 17.0 m † | SEC (XBRL)· 12 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 | -743.3 k | -4.3 m | -5.4 m | -4.9 m | -319.7 k | 462.4 k | SEC (XBRL)· 12 Mar 2026verified |
| Capex | 920.6 k | 346.2 k | 2.8 m | 782.9 k | 1.3 m | 932.5 k | SEC (XBRL)· 12 Mar 2026verified |
| Free cash flow | -1.7 m ≈ | -4.7 m ≈ | -8.2 m ≈ | -5.7 m ≈ | -1.6 m ≈ | -470.1 k ≈ | SEC (XBRL)· 12 Mar 2026derived |
| Investing cash flow | -1.0 m | -366.2 k | -2.8 m | -814.6 k | -1.3 m | -949.8 k | SEC (XBRL)· 12 Mar 2026verified |
| Financing cash flow | 23.2 m | 2.7 m | 279.5 k | -218.9 k | -248.5 k | -221.4 k | SEC (XBRL)· 12 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: 151.0 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 | -4.0% | 53 (vs peers) | 23% |
| FCF conversion · Quality | unavailable | unavailable | — |
| Revenue CAGR 3Y · Growth | 13.8% | 100 (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 | 2.7x | 100 (on a fixed band) | 15% |
| P/E (TTM) · Valuation | unavailable | unavailable | — |
| EV/EBITDA · Valuation | unavailable | unavailable | — |
| FCF yield · Valuation | 0.5% | 6 (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· partial100/100 · 1/3 factors with a value
- Growth· partial100/100 · 1/2 factors with a value
- Quality· partial53/100 · 1/3 factors with a value
- Returns· partialunavailable · 0/2 factors with a value
- Valuation· partial6/100 · 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
KORU MEDICAL SYSTEMS, INC. (KRMD). Latest full fiscal year: 2025; data up to 2026-06-30.
Figures computed from the financial statements: revenue 41.1 m USD in 2025; YoY growth 22.2%; net margin -4.0%; ROE -10.5%.
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
- Revenue CAGR 3Y: 13.8%
- Current ratio: 2.7x
What contradicts it
- FCF yield: 0.5%
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
Surgical & Medical Instruments & Apparatus (SIC 3841) · same industry (4-digit SIC) · compared with 39 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 | |
|---|---|---|---|---|---|---|
| SYKStryker Corp | 129.3 bn | 36.2 | 16.0% | 13.8% | +11.2% | −8% / +15% |
| MMM3m Company | 100.2 bn | 28.9 | 80.8% | 14.0% | +1.5% | +13% / +134% |
| BSXBoston Scientific Corporation | 66.4 bn | 19.4 | 14.3% | 16.6% | +19.9% | −55% / −18% |
| BDXBecton, Dickinson And Company | 57.0 bn | 63.2 | 3.8% | 4.0% | +8.2% | +37% / +13% |
| RMDResMed Inc. | 33.8 bn | 21.9 | 26.4% | 27.8% | +9.9% | −6% / +52% |
| DXCMDexcom, Inc. | 33.0 bn | 34.8 | 37.7% | 19.4% | +15.6% | +39% / −23% |
| WSTWest Pharmaceutical Services, Inc. | 28.5 bn | 45.9 | 21.2% | 18.8% | +6.3% | +47% / +17% |
| GKOSGLAUKOS Corp | 14.6 bn | — | -22.8% | -24.6% | +32.3% | +132% / +286% |
| BAXBaxter International Inc. | 13.7 bn | — | -10.5% | -6.2% | +5.7% | +41% / −27% |
| PODDInsulet Corporation | 11.4 bn | 26.9 | 28.9% | 13.4% | +30.7% | −50% / −13% |
| TFXTeleflex Incorporated | 6.4 bn | — | -28.9% | -45.8% | +17.2% | +31% / −34% |
| HAEHaemonetics Corporation | 5.8 bn | 62.3 | 11.2% | 7.1% | −2.0% | +57% / +58% |
| ICUIIcu Medical Inc | 4.3 bn | 144.2 | 1.4% | 1.4% | −6.3% | +16% / +97% |
| LMATLemaitre Vascular, Inc. | 2.0 bn | 30.9 | 16.8% | 25.0% | +13.5% | +6% / +67% |
| KMTSKestra Medical Technologies, Ltd. | 1.8 bn | — | -73.7% | -140.4% | +59.0% | +13% / unavailable |
| IARTIntegra Lifesciences Holdings Corp | 1.2 bn | 88.3 | 1.2% | 0.8% | +1.5% | +13% / −62% |
| SIBNSi-Bone, Inc. | 1.1 bn | — | -7.7% | -6.2% | +20.2% | +28% / +32% |
| MDXGMimedx Group, Inc. | 467.0 m | — | -8.5% | -6.3% | +20.0% | −53% / −59% |
| CARLCarlsmed, Inc. | 439.3 m | — | -6,196.9% | -57.4% | +85.9% | −1% / unavailable |
| BWAYBrainsway Ltd. | 439.0 m | 224.2 | 5.6% | 7.1% | +29.0% | +28% / +258% |
| OFIXOrthofix Medical Inc. | 395.9 m | — | -13.9% | -7.4% | +2.9% | −40% / −12% |
| CTSOCytosorbents Corporation | 286.6 m | — | -336.2% | -48.9% | +4.1% | −72% / −81% |
| UTMDUtah Medical Products, Inc. | 230.6 m | 22.1 | 8.8% | 29.0% | −5.8% | +29% / −14% |
| KRMDKoru Medical Systems, Inc. | 151.0 m | — | -10.5% | -4.0% | +22.2% | −15% / +47% |
| LUNGPulmonx Corporation | 123.2 m | — | -90.3% | -47.9% | +8.0% | +75% / −74% |
1- and 3-year price returns: for KRMD 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
KORU Medical Systems develops, manufactures and sells large-volume subcutaneous infusion systems, used mainly for home delivery of subcutaneous immunoglobulin. The company reported 22.2% revenue growth in fiscal 2025, with net revenues of 41.1 million USD, and updated its 2026 guidance to revenue of 47.5 - 48.5 million USD.
SWOT
Strengths
- The company has a portable mechanical system that needs no batteries or electricity and is described as the market-leading delivery system in the US for subcutaneous immunoglobulin.
- Revenue growth in fiscal 2025 and in the second quarter of 2026 was supported by higher volumes and share gains in existing and new accounts.
- The company reported net income in the second quarter of 2026 after a loss in the prior year period, which points to improved operating efficiency.
Weaknesses
- The company depends on a small number of distributors, and a single US distributor contributed a significant share of revenues.
- Most components come from single-source suppliers, and consumables are partly made by a contract manufacturer in Nicaragua.
- Cash availability is modest relative to the size of operations, and the company could need additional financing if its strategic plans expand.
Opportunities
- The SCIg market and expanding indications could open new accounts and new countries for the FREEDOM system.
- The large number of high-volume drugs in clinical development offers potential for NRE services and agreements with drug companies.
- The connected monitoring technology acquired in 2026 could differentiate the platform and provide useful data on patient usage.
Threats
- If plasma-derived immunoglobulin supply is disrupted, demand for the company's systems could decline.
- Competitors with greater financial resources or lower prices could reduce the company's market share.
- Tariffs, raw material costs and changes in FDA regulation could affect margins and the ability to sell products.
Risks
- Dependence on distributorshigh
A small number of distributors account for most sales, and changing the distribution model could be costly and slow.
- Single-source suppliershigh
Components and raw materials come from single suppliers, and a supply interruption could affect production and sales.
- Outsourced productionmedium
An important part of consumables is made by a contractor in Nicaragua, which could delay deliveries in case of interruption.
- FDA regulationmedium
The company must meet FDA and foreign authority requirements, and any findings could limit the marketing of its products.
- Liquidity and financingmedium
The company could need additional capital if its growth strategy accelerates, which could dilute current shareholders.
Investment thesis
What would need to be true (bull case)
- Revenue growth accelerated in fiscal 2025 and in the second quarter of 2026, and the company reported net income in a quarter after prior losses.
- The subcutaneous immunoglobulin market keeps growing, and the FREEDOM system is widely used in the US for this therapy.
- The acquisition of a connected monitoring asset and the strategy for other drugs could extend the platform's value beyond the current market.
What would break the thesis
- Most revenue depends on a small number of distributors and on one US distributor, which could make results volatile.
- Gross margin declined in fiscal 2025, and cost and tariff pressures could limit margin recovery.
- The company withdrew a 510(k) application for an oncology product in the US, which shows some expansion plans could be delayed.
What to watch
- Development of international revenue after prefilled syringe conversions in EuropeQ3 2026
- Delivery against full-year revenue and gross margin guidance2026
- Results from the connected monitoring asset and any new supply agreementsnext 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
KORU Medical develops, manufactures and commercializes large-volume subcutaneous infusion solutions, focused mainly on the subcutaneous drug delivery market. Its core product is the FREEDOM system, which includes the FREEDOM60 and FreedomEdge syringe drivers, HIgH-Flo needle sets and Precision Flow Rate Tubing. The systems are portable, need no batteries or electricity and are used either at the patient's home or in infusion centers.
Revenue comes from three sources: the domestic core business in the US and Canada, the international core business, and pharma services and clinical trials. In the last segment the company supplies products for clinical trials and performs non-recurring engineering services to adapt the FREEDOM system to new drugs. Most products are sold through distributors, and the nine main distributors represented about 77% of net revenues as of December 31, 2025.
The strategy aims to strengthen leadership in large-volume (above 10 ml) subcutaneous infusion, especially for subcutaneous immunoglobulin, and to extend into new subcutaneous therapies. As a growth lever, KORU aims to help drive the broad transition to prefilled syringes, and its development also includes the acquisition of a connected monitoring technology asset.
Market context
The company points to growth in the subcutaneous immunoglobulin (SCIg) market, supported by more frequent diagnoses of primary immunodeficiency, expanding indications and patient preference for home treatment with a more favorable side-effect profile than IVIg. The company estimates that at least 170 large-volume drugs in clinical development could use subcutaneous infusion, which points to a broader potential market beyond SCIg.
Dependence on donated plasma and on the supply chains of immunoglobulin makers remains a key factor. Gaining market share also depends on distributor relationships and on the company's ability to obtain approvals for new drugs, and these outcomes are not assured.
Trends
- Shift to prefilled syringesmixed
Drug makers are increasingly moving to prefilled syringes, which could open new opportunities for the FREEDOM system but may also create uneven demand patterns in some European markets.
- Growth in SCIg and PIDD diagnosestailwind
More frequent diagnoses of primary immunodeficiency and expanding SCIg indications support demand for home treatment, which is the company's main channel.
- Cost and tariff pressureheadwind
Higher material, tariff and freight costs reduced gross margin in 2025, and these pressures could persist unless offset by better pricing.
- Concentration of distribution and purchasingmixed
Consolidation among distributors and healthcare providers can give buyers more negotiating power, but it can also increase the company's dependence on a few large partners.
Competitive position
KORU Medical competes in an infusion market with several kinds of rivals: makers of electronic volumetric pumps, elastomeric infuser pumps, other mechanical devices and new drug delivery methods or formulations that allow smaller volumes. Some competitors are large medical device companies with greater financial and marketing resources.
Competition is based on product features, clinical and economic outcomes, quality, availability and price. Former employees could also develop competing products, and industry consolidation could intensify pressure on prices.
- Large medical device companies with multiple product lines
The company's risk disclosure cites rivals with greater financial and marketing resources, without naming a specific company.
- Makers of electronic volumetric pumps
Electronic pumps offer an alternative to the mechanical FREEDOM system, according to the annual report description.
- Makers of elastomeric infuser pumps
Elastomeric pumps are another device category that can compete for the same indications.
- Specialized companies focused on particular products or markets
Some competitors are more specialized and may offer products at lower price points, according to the company's risk factors.
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 report14 Aug 2026Amendments to articles or bylaws · Financial statements and exhibits
- Quarterly report05 Aug 2026
- Current report05 Aug 2026Results of operations · Financial statements and exhibits
- Current report30 Jun 2026Material agreement · Financial statements and exhibits
- Current report21 May 2026Shareholder vote
- Quarterly report06 May 2026
- Current report06 May 2026Results of operations · Financial statements and exhibits
- Proxy statement09 Apr 2026
- Current report03 Apr 2026Material agreement · Creation of a direct financial obligation · Financial statements and exhibits
- Current report16 Mar 2026Departure or appointment of officers · Financial statements and exhibits
Sources
- [1] Form 10-K, fiscal year ended 2025-12-31 · SEC / KORU Medical Systems, Inc. · 12 Mar 2026
- [2] Form 8-K, results release (exhibit 99.1) · SEC / KORU Medical Systems, Inc. · 05 Aug 2026
Figures computed by olivLaw from SEC filings and closing prices; the qualitative analysis is AI-generated from cited sources. Not investment advice.