olivLaw · US equity research
ClearPoint Neuro, Inc. CLPT
Surgical & Medical Instruments & Apparatus · SIC 3841 · Vertical: Surgical & Medical Instruments & Apparatus (SIC 3841)
ClearPoint Neuro develops and commercializes navigation systems for minimally invasive neurosurgery in the brain and provides preclinical services for pharmaceutical companies developing gene and cell therapies. The company expanded its portfolio through the IRRAS acquisition in 2025, and second quarter 2026 revenue was $10.9 million, with annual guidance of $48.0-52.0 million.
The AI analysis may be outdated: new filings came after its sources (see the «AI analysis» section).
At the close of 04 Nov 2026, ClearPoint Neuro, Inc. (CLPT) stock was 10.16 USD (+4.63% on the day), with market capitalisation 325.7 m USD, beta 1.95, 52-week range 8.66–19.43 USD. Latest reported quarter (Q3 2026): revenue of 12.1 m USD (+36.3% YoY), net income of -7.5 m USD, diluted EPS -0.24 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)
- 45.6
- neutral
- Bollinger (20, 2)
- 8.65 – 10.91
- in the upper half of the band · %B 0.67 · band width 23.1%
- SMA 50 / 200
- 12.15 / 12.90
- downtrend (price < SMA50 < SMA200)
- MACD (12, 26, 9)
- -0.55 / -0.78
- 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 | −11.8% | −1.1% | −10.7 pp | — |
| 3 months | −22.8% | −0.5% | −22.3 pp | — |
| 6 months | −11.4% | +4.4% | −15.8 pp | — |
| Year to date | −25.7% | +12.3% | −38.0 pp | — |
| 1 year | −42.0% | +13.5% | −55.6 pp | −2.7% |
| 3 years | +66.6% | +76.4% | −9.9 pp | +14.6% |
| 5 years | −44.6% | +63.7% | −108.3 pp | — |
Price returns, dividends excluded.
Quarterly results
Latest quarter: Q3 2026 · 30 Sept 2026
Quarterly margins
Quarterly statements · USD
| Fiscal year | Q4 '24 | Q1 '25 | Q2 '25 | Q3 '25 | Q4 '25 | Q1 '26 | Q2 '26 | Q3 '26 |
|---|---|---|---|---|---|---|---|---|
| Revenue | 7.8 m | 8.5 m | 9.2 m | 8.9 m | 10.4 m | 12.1 m | 10.9 m | 12.1 m |
| Cost of revenue | 3.0 m | 3.4 m | 3.7 m | 3.3 m | 4.0 m | 4.4 m | 4.2 m | 5.0 m |
| Gross profit | 4.8 m | 5.1 m | 5.6 m | 5.6 m | 6.4 m | 7.8 m | 6.7 m | 7.1 m |
| Research & development | 3.3 m | 3.4 m | 3.8 m | 3.5 m | 3.2 m | 4.5 m | 4.6 m | 4.0 m |
| SG&A | 3.3 m | 4.1 m | 3.4 m | 3.6 m | 5.4 m | 5.0 m | 5.6 m | 3.8 m |
| Operating income | -5.6 m | -6.2 m | -5.7 m | -5.3 m | -7.0 m | -8.5 m | -10.2 m | -6.3 m |
| Depreciation & amortisation | 240.0 k | 103.0 k | 396.0 k ≈ | 66.0 k ≈ | 249.0 k | 86.0 k | 150.0 k ≈ | 103.0 k ≈ |
| Interest expense | — | 0 | 365.0 k | 939.0 k | 1.1 m | 1.4 m | 1.4 m | 1.4 m |
| Pre-tax income | -5.4 m | -6.0 m | -5.8 m | -5.9 m | -7.8 m | -9.5 m | -11.4 m | -7.5 m |
| Income tax | -32.0 k | 18.0 k | 25.0 k | 8.0 k | 4.0 k | 8.0 k | -38.0 k | -4.0 k |
| Net income | -5.4 m | -6.0 m | -5.8 m | -5.9 m | -7.8 m | -9.6 m | -11.3 m | -7.5 m |
| Diluted EPS | -0.20 ≈ | -0.22 | -0.21 | -0.21 | -0.27 ≈ | -0.32 | -0.38 | -0.24 |
| Operating cash flow | -1.2 m | -6.2 m | -2.6 m ≈ | -3.1 m ≈ | -12.1 m | -8.0 m | -7.0 m ≈ | -20.1 m |
| Capex | 263.0 k | 183.0 k | 91.0 k ≈ | 199.0 k ≈ | 49.0 k | 645.0 k | 214.0 k ≈ | 137.0 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 | 7.4 m | 11.2 m | 12.8 m | 16.3 m | 20.6 m | 24.0 m | 31.4 m | 37.0 m |
| Revenue YoY | −0.4% | — | +14.4% | +27.0% | +26.1% | +16.6% | +31.0% | +17.8% |
| Net income | -6.2 m | -5.5 m | -6.8 m | -14.4 m | -16.4 m | -22.1 m | -18.9 m | -25.5 m |
| Net income YoY | unavailable | — | unavailable | unavailable | unavailable | unavailable | unavailable | unavailable |
| Diluted EPS | unavailable | unavailable | unavailable | -0.69 | -0.68 | -0.90 | -0.70 | -0.90 |
| Diluted EPS YoY | unavailable | — | unavailable | unavailable | unavailable | unavailable | unavailable | unavailable |
| net % | -83.8% | -49.4% | -52.9% | -88.4% | -80.0% | -92.2% | -60.3% | -69.1% |
| Free cash flow | -4.7 m | -2.9 m | -7.8 m | -12.9 m | -16.4 m | -14.4 m | -9.2 m | -24.4 m |
The series breaks before 2019: 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
- 45.9 m USD
- Financial debt
- 49.1 m USD
- Net debt
- 3.2 m USD
- Equity
- 28.0 m USD
- Total assets
- 97.7 m USD
- Debt / equity
- 1.75x
- Current ratio
- 5.91x
- ROE
- -95.6%
- ROA
- -37.3%
- FCF margin
- -66.1%
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 | 12.8 m | 16.3 m | 20.6 m | 24.0 m | 31.4 m | 37.0 m | SEC (XBRL)· 17 Mar 2026verified |
| Cost of revenue | 3.7 m | 5.2 m | 7.0 m | 10.3 m | 12.3 m | 14.3 m | SEC (XBRL)· 17 Mar 2026verified |
| Gross profit | 9.1 m | 11.1 m | 13.5 m | 13.6 m | 19.1 m | 22.7 m | SEC (XBRL)· 17 Mar 2026verified |
| Research & development | 4.7 m | 9.3 m | 10.9 m | 11.7 m | 12.4 m | 13.9 m | SEC (XBRL)· 17 Mar 2026verified |
| SG&A | 5.3 m | 8.0 m | 9.6 m | 11.8 m | 12.0 m | 16.5 m | SEC (XBRL)· 17 Mar 2026verified |
| Operating income | -6.2 m | -13.4 m | -16.3 m | -22.4 m | -19.7 m | -24.2 m | SEC (XBRL)· 17 Mar 2026verified |
| Depreciation & amortisation | 334.0 k | 159.0 k | 244.0 k | 626.0 k | 980.0 k | 814.0 k | SEC (XBRL)· 17 Mar 2026verified |
| EBITDA | -5.9 m ≈ | -13.2 m ≈ | -16.1 m ≈ | -21.8 m ≈ | -18.8 m ≈ | -23.4 m ≈ | SEC (XBRL)· 17 Mar 2026derived |
| Interest expense | 1.4 m | 973.0 k | 81.0 k | — | 518.0 k | 2.4 m | SEC (XBRL)· 17 Mar 2026verified |
| Pre-tax income | — | — | — | — | -18.9 m | -25.5 m | SEC (XBRL)· 17 Mar 2026verified |
| Income tax | 0 | 0 | 0 | 8.0 k | 12.0 k | 55.0 k | SEC (XBRL)· 17 Mar 2026verified |
| Net income | -6.8 m | -14.4 m | -16.4 m | -22.1 m | -18.9 m | -25.5 m | SEC (XBRL)· 17 Mar 2026verified |
| Diluted EPS | — | -0.69 | -0.68 | -0.90 | -0.70 | -0.90 | SEC (XBRL)· 17 Mar 2026verified |
| Weighted average diluted shares | — | 20.7 m | 24.2 m | 24.6 m | 27.0 m | 28.3 m | SEC (XBRL)· 17 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 | 20.1 m | 54.1 m | 27.6 m | 23.1 m | 20.1 m | 45.9 m | SEC (XBRL)· 17 Mar 2026verified |
| Receivables | 1.9 m | 2.3 m | 2.7 m | 3.2 m | 4.7 m | 6.5 m | SEC (XBRL)· 17 Mar 2026verified |
| Inventories | 3.2 m | 4.9 m | 9.3 m | 7.9 m | 6.9 m | 8.4 m | SEC (XBRL)· 17 Mar 2026verified |
| Current assets | 25.5 m | 61.9 m | 51.2 m | 36.2 m | 33.4 m | 63.6 m | SEC (XBRL)· 17 Mar 2026verified |
| Property, plant & equipment, net | 319.0 k | 539.0 k | 806.0 k | 1.4 m | 2.0 m | 2.6 m | SEC (XBRL)· 17 Mar 2026verified |
| Goodwill | — | — | — | — | 7.5 m | 7.5 m | SEC (XBRL)· 17 Mar 2026verified |
| Intangibles (excl. goodwill) | — | — | — | — | 0 | 13.9 m | SEC (XBRL)· 17 Mar 2026verified |
| Total assets | 29.5 m | 65.6 m | 55.5 m | 42.7 m | 39.2 m | 97.7 m | SEC (XBRL)· 17 Mar 2026verified |
| Accounts payable | 300.0 k | 427.0 k | 272.0 k | 393.0 k | 1.3 m | 1.3 m | SEC (XBRL)· 17 Mar 2026verified |
| Long-term debt | 21.3 m | 9.8 m | 9.9 m | 9.9 m | — | 49.1 m | SEC (XBRL)· 17 Mar 2026verified |
| Current liabilities | 3.2 m | 4.8 m | 6.8 m | 7.4 m | 10.4 m | 10.8 m | SEC (XBRL)· 17 Mar 2026verified |
| Total liabilities | 27.1 m | 16.8 m | 18.6 m | 21.5 m | 13.8 m | 69.7 m | SEC (XBRL)· 17 Mar 2026verified |
| Equity | 2.4 m † | 48.8 m † | 36.9 m † | 21.2 m † | 25.4 m † | 28.0 m † | SEC (XBRL)· 17 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 | -7.8 m | -12.7 m | -16.2 m | -13.7 m | -9.0 m | -23.9 m | SEC (XBRL)· 17 Mar 2026verified |
| Capex | 41.0 k | 168.0 k | 253.0 k | 717.0 k | 275.0 k | 522.0 k | SEC (XBRL)· 17 Mar 2026verified |
| Free cash flow | -7.8 m ≈ | -12.9 m ≈ | -16.4 m ≈ | -14.4 m ≈ | -9.2 m ≈ | -24.4 m ≈ | SEC (XBRL)· 17 Mar 2026derived |
| Investing cash flow | -482.0 k | -168.0 k | -10.7 m | 8.9 m | -275.0 k | 615.0 k | SEC (XBRL)· 17 Mar 2026verified |
| Financing cash flow | 22.7 m | 46.9 m | 409.0 k | 296.0 k | 6.2 m | 50.2 m | SEC (XBRL)· 17 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
- score weight coverage: 43.8% 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: 325.7 m USD
Key indicators
Coverage and freshness
Score by group
44% · 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 base of the ratio is not positive
- Peers: EV/EBITDAunavailable · the base of the ratio is not positive
- 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: score weight coverage: 43.8% of at least 60%; valuation methods computed: 0 of at least 1
| Factor | Value | Score | Weight used |
|---|---|---|---|
| ROIC · Quality | -139.1% | 11 (vs peers) | 24% |
| Net margin · Quality | -79.4% | 11 (vs peers) | 14% |
| FCF conversion · Quality | unavailable | unavailable | — |
| Revenue CAGR 3Y · Growth | 21.6% | 100 (on a fixed band) | 19% |
| EPS CAGR 3Y · Growth | unavailable | unavailable | — |
| Net debt / EBITDA · Balance sheet | unavailable | unavailable | — |
| Interest coverage · Balance sheet | -6.0x | 0 (on a fixed band) | 14% |
| Current ratio · Balance sheet | 6.8x | 100 (on a fixed band) | 10% |
| P/E (TTM) · Valuation | unavailable | unavailable | — |
| EV/EBITDA · Valuation | unavailable | unavailable | — |
| FCF yield · Valuation | -14.8% | 0 (on a fixed band) | 19% |
| 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 sheet40/100 · 2/3 factors with a value
- Growth· partial100/100 · 1/2 factors with a value
- Quality11/100 · 2/3 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
ClearPoint Neuro, Inc. (CLPT). Latest full fiscal year: 2025; data up to 2026-09-30.
Figures computed from the financial statements: revenue 37.0 m USD in 2025; YoY growth 17.8%; net margin -79.4%; ROE -167.5%.
Valuation cannot be computed from the available data.
Insufficient data for a verdict (score weight coverage: 43.8% 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: 21.6%
- Current ratio: 6.8x
What contradicts it
- ROIC: -139.1%
- Net margin: -79.4%
- Interest coverage: -6.0x
- FCF yield: -14.8%
Not assessed (insufficient data or a ratio without meaning): FCF conversion, EPS CAGR 3Y, Net debt / EBITDA, 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% |
| SOLVSolventum Corporation | 15.2 bn | 10.9 | 34.0% | 17.3% | +0.9% | +5% / unavailable |
| PENPenumbra, Inc | 12.7 bn | 81.2 | 10.7% | 10.1% | +17.5% | +10% / +45% |
| GMEDGlobus Medical, Inc. | 11.7 bn | 22.3 | 11.8% | 17.0% | +16.7% | −4% / +94% |
| 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% |
| MMSIMerit Medical Systems Inc | 5.4 bn | 34.0 | 9.8% | 9.9% | +11.8% | +5% / +27% |
| HTFLHeartflow, Inc. | 4.9 bn | — | — | -55.8% | +39.9% | +75% / unavailable |
| 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% |
| TNDMTandem Diabetes Care, Inc. | 1.3 bn | — | -48.0% | -6.1% | +7.9% | −9% / −6% |
| IARTIntegra Lifesciences Holdings Corp | 1.2 bn | 88.3 | 1.2% | 0.8% | +1.5% | +13% / −62% |
| BBNXBeta Bionics, Inc. | 921.5 m | — | -23.9% | -65.3% | +53.9% | −46% / unavailable |
| SGHTSight Sciences, Inc. | 538.0 m | — | -50.1% | -32.1% | −3.1% | +16% / +184% |
| SSIISs Innovations International, Inc. | 454.9 m | — | -26.1% | -23.7% | +105.7% | −66% / unavailable |
| 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% |
| EMBCEmbecta Corp. | 369.4 m | 4.4 | — | 8.6% | −3.8% | −49% / −64% |
| CLPTClearPoint Neuro, Inc. | 325.7 m | — | -167.5% | -79.4% | +17.8% | −42% / +67% |
1- and 3-year price returns: for CLPT 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.
Possibly outdated: the newest document it read is from 03 Aug 2026; since then the company filed 8-K (28 Oct 2026 · results), 10-Q (28 Oct 2026).
In brief
ClearPoint Neuro develops and commercializes navigation systems for minimally invasive neurosurgery in the brain and provides preclinical services for pharmaceutical companies developing gene and cell therapies. The company expanded its portfolio through the IRRAS acquisition in 2025, and second quarter 2026 revenue was $10.9 million, with annual guidance of $48.0-52.0 million.
SWOT
Strengths
- The company has an integrated portfolio of FDA-cleared products and a network of more than 60 pharmaceutical and academic partners.
- The IRRAS acquisition brought a differentiated intracranial fluid management product with FDA and CE clearances.
- Sustained investment in its navigation and delivery ecosystem gives the company a specialized position in neurosurgery.
Weaknesses
- Biologics revenue is sensitive to one-off orders and to partners' trial timelines, which makes quarterly results hard to forecast.
- Operating expenses rose sharply after the acquisition, and operating cash burn remains significant.
- IRRAflow runs at sub-scale production, which weighs on unit costs and could lower overall gross margins in the near term.
Opportunities
- Approvals of gene and cell therapies could increase demand for the company's intracerebral delivery systems.
- The new preclinical laboratory and GLP services could generate recurring study revenue from partners.
- Focused ultrasound and robotics could open new markets if these technologies move beyond the preclinical stage.
Threats
- Dependence on regulatory decisions and partner funding could delay projects and reduce revenue.
- Competitors with greater financial resources could expand their offerings in brain stimulation and laser therapy.
- If the IRRAS integration takes longer or synergies do not materialize, financial performance could suffer.
Risks
- Dependence on biotech partnershigh
Revenue depends on pharmaceutical and academic programs, which can be reduced, delayed or stopped for financial or clinical reasons.
- Integration of the IRRAS acquisitionhigh
Integrating systems, culture and personnel can be costly and slow, and anticipated synergies may not be achieved.
- Limited liquidityhigh
Declining cash and reliance on a debt facility with an affiliated lender could limit financial flexibility.
- Uncertain future approvalsmedium
Expanding IRRAflow indications or launching new products depends on FDA decisions, which are not assured.
- Macroeconomic pressuremedium
Inflation, interest rates and hospital budget constraints could reduce procedure volumes and demand for products.
Investment thesis
What would need to be true (bull case)
- If gene and cell therapies receive approvals within the expected period, the company could benefit from higher demand for direct brain delivery through its product and service ecosystem.
- Growth in navigation and therapy revenue, supported by IRRAflow and the version 3.0 software, shows the device segment could become a growth driver.
- Its relationships with a large partner network and expanded preclinical capacity could make the company a central provider for clinical studies in the coming years.
What would break the thesis
- The biologics segment declined in the latest quarter, and reliance on one-off orders could keep revenue unstable from quarter to quarter.
- Operating expenses rose substantially after the acquisition, and if revenue does not cover them, cash pressure could persist.
- Annual guidance was adjusted, and if clinical or regulatory adoption is slower, meeting targets could prove difficult.
What to watch
- Biologics segment revenue after the CAL laboratory comes into operationQ3 2026
- Achievement of annual revenue guidance2026
- Cash position and operating cash burn in the second half of the yearQ3 2026
- FDA decisions on partners' potential BLA submissions2027
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.
Possibly outdated: the newest document it read is from 03 Aug 2026; since then the company filed 8-K (28 Oct 2026 · results), 10-Q (28 Oct 2026).
The business
ClearPoint Neuro is a commercial-stage medical device company incorporated in 1998 as a Delaware corporation with two integrated components. The first is the ClearPoint system, an integrated set of hardware, disposables and software used to guide insertion of deep brain stimulation electrodes, biopsy needles and laser catheters, and to infuse pharmaceuticals into the brain. The second focuses on partnerships in biologics and drug delivery, offering preclinical and consulting services. The IRRAS acquisition, closed in the fourth quarter of 2025, added the IRRAflow system for neurocritical care.
Segments
Biologics and drug delivery
This segment covers preclinical services, consulting and products sold to partners injecting gene and cell therapies directly into the brain. Revenue in this segment fell 15% in the second quarter of 2026, due to a single customer order in the prior year that did not recur. The company says the new CAL laboratory in Torrey Pines could return the segment to growth in the third quarter.
Trends
- More favorable regulatory path for gene and cell therapiestailwind
Partners have received positive FDA feedback on potential BLA submissions, which could bring additional therapies to market by the end of 2027. If these approvals materialize, demand for intracerebral delivery systems could increase.
- Funding constraints in biotechnologyheadwind
The company notes that partner funding, tied to capital markets and government research budgets, can lead partners to delay, scale back or discontinue programs. This could affect revenue in the biologics segment.
- Hospital budgets under pressureheadwind
Macroeconomic pressure and reduced public funding may limit hospital investment in new equipment, which could slow adoption of the ClearPoint and IRRAflow systems.
- Expansion into focused ultrasound and roboticsmixed
A partnership with a South Korean laboratory for focused ultrasound drug delivery, together with the robotic platform in development, could diversify the portfolio, but both remain at a preclinical stage and carry execution risk.
Competitive position
In deep brain stimulation, large manufacturers of DBS systems compete, and in responsive neuromodulation only one commercial system is on the market. In laser thermal therapy, competitors include other device makers with FDA-cleared systems. In drug delivery, the company differentiates through its combination of products and preclinical services, though the source gives no market share figure.
- MedtronicMDT
Maker of deep brain stimulation systems with FDA clearances for Parkinson's disease and essential tremor, named in the source as a DBS competitor.
- Boston ScientificBSX
Maker of DBS systems with FDA clearance for Parkinson's disease and essential tremor, named in the source.
- NeuroPace
Company whose brain-responsive neuromodulation system is the only commercially available RNS system, approved for drug-resistant focal epilepsy.
- Monteris Medical
Maker of the NeuroBlate laser interstitial thermal therapy system, named in the source as a LITT competitor.
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
- Quarterly report28 Oct 2026
- Current report28 Oct 2026Results of operations · Regulation FD disclosure · Financial statements and exhibits
- Quarterly report03 Aug 2026
- Current report03 Aug 2026Results of operations · Regulation FD disclosure · Financial statements and exhibits
- Current report21 May 2026Departure or appointment of officers · Shareholder vote · Financial statements and exhibits
- Quarterly report13 May 2026
- Current report13 May 2026Results of operations · Regulation FD disclosure · Financial statements and exhibits
- Proxy statement10 Apr 2026
- Annual report17 Mar 2026
- Current report17 Mar 2026Results of operations · Regulation FD disclosure · Financial statements and exhibits
Sources
- [1] Form 10-K, fiscal year ended 2025-12-31 · SEC / ClearPoint Neuro, Inc. · 17 Mar 2026
- [2] Form 10-Q, quarter ended 2026-06-30 · SEC / ClearPoint Neuro, Inc. · 03 Aug 2026
- [3] Form 8-K, results release (exhibit 99.1) · SEC / ClearPoint Neuro, Inc. · 03 Aug 2026
Figures computed by olivLaw from SEC filings and closing prices; the qualitative analysis is AI-generated from cited sources. Not investment advice.