olivLaw · US equity research
Orchestra BioMed Holdings, Inc. OBIO
Surgical & Medical Instruments & Apparatus · SIC 3841 · Vertical: Surgical & Medical Instruments & Apparatus (SIC 3841)
Orchestra BioMed Holdings develops niche biomedical technologies, including the AVIM Therapy for hypertension and the Virtue SAB balloon, through risk-reward partnerships with large medical device companies. The company is still in its pivotal-trial phase, with a net loss of 52.7 million USD in 2025 and 110.0 million USD in cash and securities at June 30, 2026, which makes its dependence on completing trials and securing new funding relevant.
At the close of 05 Nov 2026, Orchestra BioMed Holdings, Inc. (OBIO) stock was 5.62 USD (−6.33% on the day), with market capitalisation 337.8 m USD, beta 1.59, 52-week range 3.49–6.35 USD. Latest reported quarter (Q2 2026): revenue of 88.0 k USD (−89.5% YoY), net income of -23.8 m USD, diluted EPS -0.38 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)
- 47.4
- neutral
- Bollinger (20, 2)
- 5.39 – 6.11
- in the lower half of the band · %B 0.32 · band width 12.5%
- SMA 50 / 200
- 5.73 / 4.57
- mixed trend
- MACD (12, 26, 9)
- 0.01 / 0.02
- MACD below 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 | −3.8% | −1.1% | −2.7 pp | — |
| 3 months | +35.4% | −0.5% | +35.9 pp | — |
| 6 months | +43.0% | +4.4% | +38.6 pp | — |
| Year to date | +35.4% | +12.3% | +23.1 pp | — |
| 1 year | +43.4% | +13.5% | +29.8 pp | −46.0% |
| 3 years | +7.0% | +76.4% | −69.4 pp | −23.4% |
| 5 years | −43.0% | +63.7% | −106.7 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 | 987.0 k | 253.0 k | 868.0 k | 836.0 k | 861.0 k | 30.9 m | 110.0 k | 88.0 k |
| Cost of revenue | 68.0 k | 58.0 k | 44.0 k | 46.0 k | 49.0 k | 51.0 k | 32.0 k | 25.0 k |
| Research & development | 11.6 m | 11.0 m | 13.5 m | 13.9 m | 14.0 m | 16.8 m | 15.8 m | 16.6 m |
| SG&A | 5.7 m | 5.9 m | 6.3 m | 6.3 m | 7.1 m | 7.3 m | 6.4 m | 5.8 m |
| Operating income | -16.3 m | -16.7 m | -18.9 m | -19.3 m | -20.3 m | 6.8 m | -22.1 m | -22.4 m |
| Depreciation & amortisation | 76.0 k ≈ | 84.0 k | 83.0 k | 81.0 k ≈ | 81.0 k ≈ | 82.0 k | 90.0 k | 96.0 k ≈ |
| Interest expense | 0 | 297.0 k | — | — | — | — | — | — |
| Net income | -15.4 m | -16.2 m | -18.8 m | -19.4 m | -20.8 m | 6.2 m | -20.7 m | -23.8 m |
| Diluted EPS | -0.41 | -0.42 ≈ | -0.49 | -0.50 | -0.40 | 0.10 ≈ | -0.33 | -0.38 |
| Operating cash flow | -13.7 m ≈ | -13.5 m | -16.6 m | -15.5 m ≈ | -14.6 m ≈ | -2.3 m | -22.2 m | -19.3 m ≈ |
| Capex | 68.0 k ≈ | 106.0 k | 112.0 k | 34.0 k ≈ | 310.0 k ≈ | 33.0 k | 184.0 k | 254.0 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 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|
| Revenue | unavailable | 3.5 m | 2.8 m | 2.6 m | 33.5 m |
| Revenue YoY | unavailable | unavailable | −21.9% | −4.4% | +1,169.2% |
| Net income | -378.8 k | -33.6 m | -49.1 m | -61.0 m | -52.7 m |
| Net income YoY | unavailable | unavailable | unavailable | unavailable | unavailable |
| Diluted EPS | -0.02 | -2.24 | -1.48 | -1.66 | -1.11 |
| Diluted EPS YoY | unavailable | unavailable | unavailable | unavailable | unavailable |
| net % | unavailable | -951.3% | -1,779.7% | -2,313.3% | -157.4% |
| Free cash flow | unavailable | -29.9 m | -46.2 m | -50.8 m | -49.5 m |
Reported results vs expectations
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Balance sheet & financial health
Fiscal year 2025 · 31 Dec 2025
- Cash
- 34.7 m USD
- Financial debt
- 15.0 m USD
- Net debt
- -19.7 m USD
- Equity
- 53.6 m USD
- Total assets
- 114.9 m USD
- Debt / equity
- 0.28x
- Current ratio
- 6.45x
- ROE
- -121.8%
- ROA
- -55.2%
- FCF margin
- -147.7%
Financial statements (source on every figure)
Revenue and net income (USD)
Margins
Income statement · USD
| Line | 2021 | 2022 | 2023 | 2024 | 2025 | Source (latest year) |
|---|---|---|---|---|---|---|
| Revenue | — | 3.5 m | 2.8 m | 2.6 m | 33.5 m | SEC (XBRL)· 12 Mar 2026verified |
| Cost of revenue | — | 211.0 k | 186.0 k | 204.0 k | 190.0 k | SEC (XBRL)· 12 Mar 2026verified |
| Gross profit | — | 3.3 m ≈ | 2.6 m ≈ | 2.4 m ≈ | 33.3 m ≈ | SEC (XBRL)· 12 Mar 2026derived |
| Research & development | — | 21.9 m | 33.8 m | 42.8 m | 58.2 m | SEC (XBRL)· 12 Mar 2026verified |
| SG&A | — | 14.0 m | 20.3 m | 23.9 m | 26.9 m | SEC (XBRL)· 12 Mar 2026verified |
| Operating income | -394.8 k | -32.7 m | -51.5 m | -64.3 m | -51.8 m | SEC (XBRL)· 12 Mar 2026verified |
| Depreciation & amortisation | — | 222.0 k | 287.0 k | 308.0 k | 327.0 k | SEC (XBRL)· 12 Mar 2026verified |
| EBITDA | — | -32.4 m ≈ | -51.2 m ≈ | -64.0 m ≈ | -51.5 m ≈ | SEC (XBRL)· 12 Mar 2026derived |
| Interest expense | — | 1.3 m | 1.4 m | 297.0 k | — | SEC (XBRL)· 31 Mar 2025verified |
| Income tax | — | — | — | — | 0 | SEC (XBRL)· 12 Mar 2026verified |
| Net income | -378.8 k | -33.6 m | -49.1 m | -61.0 m | -52.7 m | SEC (XBRL)· 12 Mar 2026verified |
| Diluted EPS | -0.02 | -2.24 | -1.48 | -1.66 | -1.11 | SEC (XBRL)· 12 Mar 2026verified |
| Weighted average diluted shares | 20.5 m | 15.0 m | 33.2 m | 36.8 m | 47.7 m | SEC (XBRL)· 12 Mar 2026verified |
≈ computed by olivLaw from the reported lines of the same year: Revenue − Cost of revenue; Operating income + Depreciation & amortisation.
Balance sheet · USD
| Line | 2021 | 2022 | 2023 | 2024 | 2025 | Source (latest year) |
|---|---|---|---|---|---|---|
| Cash | 1.8 m | 19.8 m | 30.6 m | 22.3 m | 34.7 m | SEC (XBRL)· 12 Mar 2026verified |
| Receivables | — | 96.0 k | 99.0 k | 92.0 k | 95.0 k | SEC (XBRL)· 12 Mar 2026verified |
| Inventories | — | 276.0 k | 146.0 k | 173.0 k | 310.0 k | SEC (XBRL)· 12 Mar 2026verified |
| Current assets | 1.8 m | 84.7 m | 89.1 m | 69.2 m | 107.9 m | SEC (XBRL)· 12 Mar 2026verified |
| Property, plant & equipment, net | — | 1.5 m | 1.3 m | 1.4 m | 1.7 m | SEC (XBRL)· 12 Mar 2026verified |
| Total assets | 161.8 m | 95.6 m | 95.2 m | 76.2 m | 114.9 m | SEC (XBRL)· 12 Mar 2026verified |
| Accounts payable | 1.4 k | 4.0 m | 2.9 m | 5.1 m | 6.1 m | SEC (XBRL)· 12 Mar 2026verified |
| Long-term debt | — | — | — | 15.0 m | 15.0 m | SEC (XBRL)· 12 Mar 2026verified |
| Current liabilities | 165.5 k | 18.6 m | 11.2 m | 16.2 m | 16.7 m | SEC (XBRL)· 12 Mar 2026verified |
| Total liabilities | 5.8 m | 43.0 m | 27.2 m | 43.2 m | 51.5 m | SEC (XBRL)· 12 Mar 2026verified |
| Equity | -19.8 m | 52.5 m | 68.0 m | 33.0 m | 53.6 m | SEC (XBRL)· 12 Mar 2026verified |
Cash flow · USD
| Line | 2021 | 2022 | 2023 | 2024 | 2025 | Source (latest year) |
|---|---|---|---|---|---|---|
| Operating cash flow | -272.4 k | -29.3 m | -46.1 m | -50.6 m | -49.0 m | SEC (XBRL)· 12 Mar 2026verified |
| Capex | — | 591.0 k | 78.0 k | 289.0 k | 489.0 k | SEC (XBRL)· 12 Mar 2026verified |
| Free cash flow | — | -29.9 m ≈ | -46.2 m ≈ | -50.8 m ≈ | -49.5 m ≈ | SEC (XBRL)· 12 Mar 2026derived |
| Investing cash flow | — | -64.1 m | 10.7 m | 13.1 m | -26.9 m | SEC (XBRL)· 12 Mar 2026verified |
| Financing cash flow | — | 103.3 m | 46.2 m | 29.2 m | 88.3 m | SEC (XBRL)· 12 Mar 2026verified |
| Dividends paid | — | 20.0 m | — | — | — | SEC (XBRL)· 25 Jan 2023verified |
≈ 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
05 Nov 2026Source: olivLaw, closing series
Market cap: 337.8 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 · input data missing
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 | -184.6% | 24 (vs peers) | 23% |
| FCF conversion · Quality | unavailable | unavailable | — |
| Revenue CAGR 3Y · Growth | 111.6% | 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 | 8.3x | 100 (on a fixed band) | 15% |
| P/E (TTM) · Valuation | unavailable | unavailable | — |
| EV/EBITDA · Valuation | unavailable | unavailable | — |
| FCF yield · Valuation | -17.5% | 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· partial100/100 · 1/3 factors with a value
- Growth· partial100/100 · 1/2 factors with a value
- Quality· partial24/100 · 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
Orchestra BioMed Holdings, Inc. (OBIO). Latest full fiscal year: 2025; data up to 2026-06-30.
Figures computed from the financial statements: revenue 33.5 m USD in 2025; YoY growth 1,169.2%; net margin -184.6%; ROE -601.8%.
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: 111.6%
- Current ratio: 8.3x
What contradicts it
- Net margin: -184.6%
- FCF yield: -17.5%
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% |
| GMEDGlobus Medical, Inc. | 10.9 bn | 20.8 | 11.8% | 17.0% | +16.7% | −11% / +81% |
| PODDInsulet Corporation | 10.8 bn | 25.4 | 28.9% | 13.4% | +30.7% | −52% / −17% |
| TFXTeleflex Incorporated | 6.4 bn | — | -28.9% | -45.8% | +17.2% | +33% / −33% |
| MMSIMerit Medical Systems Inc | 5.4 bn | 33.7 | 9.8% | 9.9% | +11.8% | +3% / +25% |
| IRTCiRhythm Holdings, Inc. | 4.3 bn | — | -9.6% | -1.7% | +26.2% | −31% / +53% |
| ICUIIcu Medical Inc | 4.2 bn | 140.0 | 1.4% | 1.4% | −6.3% | +13% / +91% |
| NVCRNovoCure Limited | 1.6 bn | — | -35.2% | -16.8% | +8.3% | +6% / +10% |
| TNDMTandem Diabetes Care, Inc. | 1.3 bn | — | -48.0% | -6.1% | +7.9% | −14% / −11% |
| ATECAlphatec Holdings, Inc. | 1.2 bn | — | -1,888.0% | -10.3% | +25.0% | −65% / −34% |
| MDXGMimedx Group, Inc. | 478.6 m | — | -8.5% | -6.3% | +20.0% | −52% / −58% |
| BWAYBrainsway Ltd. | 415.5 m | 212.2 | 5.6% | 7.1% | +29.0% | +21% / +238% |
| SSIISs Innovations International, Inc. | 380.7 m | — | -26.1% | -23.7% | +105.7% | −72% / unavailable |
| OBIOOrchestra BioMed Holdings, Inc. | 337.8 m | — | -601.8% | -184.6% | +1,169.2% | +43% / +7% |
| CLPTClearPoint Neuro, Inc. | 278.6 m | — | -167.5% | -79.4% | +17.8% | −40% / +51% |
| TMCITreace Medical Concepts, Inc. | 271.8 m | — | -72.0% | -29.0% | +1.6% | +40% / −52% |
| PROFProfound Medical Corp. | 251.3 m | — | -73.5% | -171.6% | +50.7% | +4% / −37% |
| LUCDLucid Diagnostics Inc. | 79.3 m | — | -556.3% | -959.8% | +8.3% | −63% / −74% |
| MBOTMicrobot Medical Inc. | 71.9 m | — | -32.9% | — | unavailable | −56% / −15% |
1- and 3-year price returns: for OBIO 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
Orchestra BioMed Holdings develops niche biomedical technologies, including the AVIM Therapy for hypertension and the Virtue SAB balloon, through risk-reward partnerships with large medical device companies. The company is still in its pivotal-trial phase, with a net loss of 52.7 million USD in 2025 and 110.0 million USD in cash and securities at June 30, 2026, which makes its dependence on completing trials and securing new funding relevant.
SWOT
Strengths
- The partnership model shares development costs and risks with large companies, and the Medtronic agreement provides access to global commercialization infrastructure 1.
- The portfolio includes products with FDA Breakthrough Device Designations, which can speed up interaction with regulators 1.
- The company has raised funds from several sources, including strategic partner investments and revenue-right agreements, which diversifies its access to capital 1.
Weaknesses
- The company has continuous net losses since inception and an accumulated deficit above 400 million USD, with no profitability in sight over the visible horizon 2.
- Product revenue is confined to one subsidiary, and partnership revenue is either discontinued or not yet recognized, which makes the revenue base fragile 1.
- Reliance on a small number of pivotal studies and their timing means any delay directly affects the funding plan 2.
Opportunities
- If BACKBEAT study data confirm the benefit, extending AVIM to patients without a pacemaker indication could open a significant additional market 1.
- Integration of AVIM into Medtronic's leadless pacemakers could widen the therapy's scope, according to the August 2025 amendment 1.
- If the Virtue study confirms non-inferiority, the balloon could enter a high-volume coronary market where few drug-based options exist 1.
Threats
- Failure or delay of pivotal studies could force the company to reduce or postpone development programs 1.
- Competition from companies with approved products and from partners that may develop their own solutions could reduce potential market share 1.
- The need for additional funding could lead to dilution for shareholders or to giving up product rights on less favorable terms 1.
Risks
- Continuing losses and need for capitalhigh
The company has not reached profitability and expects further losses, which could make it necessary to raise capital under difficult conditions 1.
- Regulatory and study riskhigh
Authorities could judge the data insufficient for approval, and clinical results could differ from those in earlier stages 1.
- Dependence on partnersmedium
Timing and commercial rights depend heavily on Medtronic and other partners, which may change priorities 1.
- Enrollment delaysmedium
Difficulty identifying and enrolling eligible patients could lengthen studies and delay filings 2.
- Reliance on monetizing future revenuelow
Some funding is tied to rights over future revenue, which could reduce available cash flows if sales materialize more slowly than estimated 1.
Investment thesis
What would need to be true (bull case)
- If pivotal studies produce favorable data, the company could tap a very large market through partners with existing global infrastructure.
- The partnership model could limit the company's own commercialization spending and could speed adoption in mature markets.
- Diversified funding sources and agreements with strategic investors could provide extra time to complete studies.
What would break the thesis
- Continuing losses and the accumulated deficit could force new share issuances, with dilutive effects for existing shareholders.
- Enrollment delays or an unfavorable study outcome could reduce the value of the product candidate portfolio.
- Dependence on a small number of partners and their decisions could limit the company's control over commercial timing.
What to watch
- Completion of BACKBEAT study enrollment and any changes to the timelineQ3 2026
- Presentation of BACKBEAT primary data at a major cardiovascular conferenceQ2 2027
- Completion of Virtue Trial enrollment2027
- Trend in cash and accumulated deficit in the next annual reportnext 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
Orchestra BioMed Holdings, Inc. (OBIO) presents itself as a biomedical innovation company that brings high-impact technologies to patients through strategic collaborations with leading global medical device companies. Its so-called partnership-enabled model shares the risks and rewards of development and commercialization with multinational partners, who take on commercialization infrastructure and regulatory approvals. The company was formed in 2018 from several late-stage clinical product candidates and became public through a merger with a special purpose acquisition company in January 2023 1.
Its main product candidates are AVIM Therapy, for hypertension, and Virtue SAB, a sirolimus drug-delivery angioplasty balloon for atherosclerotic artery disease. AVIM Therapy is being developed with Medtronic, which would hold the global commercial rights in the pacemaker population if the therapy is approved 1. Virtue SAB has received FDA Breakthrough Device Designation for several coronary and peripheral indications, and in October 2025 the company transferred some rights linked to Terumo through a right of first refusal agreement 1.
Revenues remain limited. To date, product revenue has come mainly from FreeHold Surgical, the subsidiary that sells intracorporeal organ retractors in the United States, while partnership revenue came largely from the Terumo agreement, fully recognized by the end of 2025 1. The company relies on funding from equity, convertible instruments, loans and the sale of future revenue rights, such as the 35.0 million USD agreement with Ligand 1.
Segments
AVIM Therapy (hypertension)
AVIM Therapy is a bioelectronic therapy that can be integrated as a firmware upgrade to pacemakers, with the aim of lowering blood pressure. The BACKBEAT pivotal study, with 284 evaluable randomized patients, is expected to complete enrollment by the end of the third quarter of 2026, and the company intends to present primary endpoint data in the second quarter of 2027 2. The potential market for pacemaker-indicated patients was estimated at over 2.4 billion USD per year 1.
Virtue SAB (artery disease)
Virtue SAB delivers a large liquid dose of extended-release sirolimus during balloon angioplasty, without balloon coating or a permanent implant. The Virtue pivotal study, planned to enroll 740 patients in the United States against Boston Scientific's AGENT balloon, has enrollment planned for completion in 2027 2. The company estimated an annual global opportunity of at least 10 billion USD for the indications granted Breakthrough status 1.
FreeHold Surgical (products)
FreeHold sells intracorporeal organ retractors exclusively in the United States, with revenue recognized when the product ships. It is the segment with current revenue, but based on the available data its contribution to the total remains small relative to research and development spending 1.
Market context
The company operates in two large, mature cardiovascular device markets. Per estimates cited in the annual report, the global cardiac rhythm management implant market was valued at 17.2 billion USD in 2024, and the interventional device market for coronary and peripheral artery disease at 26.7 billion USD in the same year 1. Both markets are dominated by multinational companies with established distribution networks, which makes strategic partnerships central to the model.
The market potential of AVIM Therapy depends on regulatory approval and integration into pacemakers, and extending the therapy to patients without a pacemaker indication could add an estimated market of over 15 billion USD if the data support it 1. The actual revenue size will depend on the partners' share and on expenses they report, which remains unclear because no revenue has yet been recognized under the amended Medtronic agreement 1.
Trends
- Shift toward bioelectronic therapies for hypertensive patientstailwind
Interest in solutions that lower blood pressure without changing standard drug treatment could support AVIM adoption if pivotal data confirm the benefit. The company stresses that hypertension is the most common comorbidity in the pacemaker population 1.
- Pressure on clinical study enrollmentheadwind
Delays in enrollment could push back the timing of regulatory filings. The company has acknowledged that it cannot assure completion of enrollment within the planned timeframes 2.
- Partnerships with large device companiesmixed
Collaborations with industry leaders can speed commercialization and reduce financial burden, but they also transfer control over timing and some commercial decisions. The Medtronic agreement illustrates this dynamic 1.
- Consolidation in the drug-coated balloon sectorheadwind
Competition in the drug-coated balloon space, where Boston Scientific has a product approved in the United States, could influence both the timing and the entry conditions for Virtue SAB 1.
Competitive position
In coronary drug-coated balloons, the company compares its Virtue study with AGENT, the only paclitaxel balloon approved in the United States for a coronary indication at the time of the filing 1. For AVIM Therapy, the main partner is Medtronic, which is also the global leader in cardiac pacing therapies, so any direct competition would mainly come from pacemaker-related and conventional antihypertensive therapies 2.
The interventional device market includes several multinational players with consolidated distribution, and the company notes that its products do not change treatment paradigms, which allows them to fit into existing portfolios 1. This lowers the adoption barrier but does not remove competitive pressure from companies that already have approved products.
- Boston Scientific CorporationBSX
Maker of the AGENT paclitaxel balloon, the only drug-coated balloon approved in the United States for a coronary indication at the report date, and the comparator in the Virtue Trial.
- MedtronicMDT
Exclusive partner for AVIM Therapy in the pacemaker population and, at the same time, a global leader in cardiac pacing therapies that could also compete through its own solutions.
- Terumo Corporation
Former distribution partner for Virtue SAB that now holds a right of first refusal on rights for coronary artery disease, following the October 2025 agreement.
- Haemonetics CorporationHAE
Company that acquired Vivasure Medical, a strategic holding previously owned by the company, and that may affect future receipts from that transaction.
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 report01 Oct 2026Regulation FD disclosure · Other events · Financial statements and exhibits
- Current report08 Sept 2026Regulation FD disclosure · Financial statements and exhibits
- Quarterly report10 Aug 2026
- Current report23 Jun 2026Shareholder vote
- Quarterly report12 May 2026
- Proxy statement29 Apr 2026
- Annual report12 Mar 2026
- Current report13 Feb 2026Departure or appointment of officers
- Current report12 Jan 2026Other events · Financial statements and exhibits
- Current report13 Nov 2025Regulation FD disclosure · Financial statements and exhibits
Sources
- [1] Form 10-K, fiscal year ended 2025-12-31 · SEC / Orchestra BioMed Holdings, Inc. · 12 Mar 2026
- [2] Form 10-Q, quarter ended 2026-06-30 · SEC / Orchestra BioMed Holdings, Inc. · 10 Aug 2026
Figures computed by olivLaw from SEC filings and closing prices; the qualitative analysis is AI-generated from cited sources. Not investment advice.