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olivLaw · US equity research

Cardio Diagnostics Holdings, Inc. CDIO

In Vitro & In Vivo Diagnostic Substances · SIC 2835 · Vertical: In Vitro & In Vivo Diagnostic Substances (SIC 2835)

1.65USD+2.81% · 1 dayClose 04 Nov 2026

Cardio Diagnostics Holdings develops and sells clinical blood tests for cardiovascular disease, built on epigenetics and an AI platform called the Multi-Omics Engine. The company is still at an early stage, with very small revenue and continuing losses, and its expansion depends largely on winning payer reimbursement, a process that can take years.

At the close of 04 Nov 2026, Cardio Diagnostics Holdings, Inc. (CDIO) stock was 1.65 USD (+2.81% on the day), with market capitalisation 4.9 m USD, beta 2.09, 52-week range 1.05–6.55 USD. Latest reported quarter (Q2 2026): revenue of 5.4 k USD (−28.3% YoY), net income of -1.5 m USD, diluted EPS -0.51 USD.

Data as of · AI analysis dated · Source: SEC filings and closing prices, computed by olivLaw.

Market cap
4.9 m USD
shares as of 07 Aug 2026
P/E (TTM)
unavailable
Diluted EPS TTM -2.92 · TTM to 30 Jun 2026
E/P (TTM)
-177.79%
TTM to 30 Jun 2026
Dividend yield
unavailable
Beta (2y)
2.09
Volatility (1y) 135%
52-week range
1.056.55

Price history

Loading chart…

Technical reading

RSI (14)
41.1
weak (30–45)
Bollinger (20, 2)
1.59 – 1.85
in the lower half of the band · %B 0.23 · band width 15.5%
SMA 50 / 200
1.85 / 2.07
downtrend (price < SMA50 < SMA200)
MACD (12, 26, 9)
-0.06 / -0.06
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

CompanyS&P 500vs S&P 500Vertical median
1 month−20.1%−1.1%−19.0 pp—
3 months−6.0%−0.5%−5.5 pp—
6 months−9.6%+4.4%−14.0 pp—
Year to date−39.3%+12.3%−51.6 pp—
1 year−54.6%+13.5%−68.1 pp−21.1%
3 years−85.3%+76.4%−161.8 pp−44.4%
5 yearsunavailable+63.7%unavailable—
Max drawdown (1y)
−79.1%
27 Feb 2026 → 19 May 2026
Max drawdown (5y)
−99.7%
17 Oct 2022 → 05 Feb 2026
Compound annual growth (5y)
unavailable
S&P 500 +10.4%

Price returns, dividends excluded.

Quarterly results

Latest quarter: Q2 2026 · 30 Jun 2026

Revenue
5.4 k USD
−28.3% YoY
Net income
-1.5 m USD
unavailable YoY
Diluted EPS
-0.51
unavailable YoY
net / operating
-28,012.5% / -27,950.5%

Quarterly margins

Quarterly statements · USD

Fiscal yearQ3 '24Q4 '24Q1 '25Q2 '25Q3 '25Q4 '25Q1 '26Q2 '26
Revenue6.6 k4.5 k9407.5 k2.9 k3.6 k2.7 k5.4 k
Research & development5.2 k204.6 k118.8 k178.5 k189.0 k286.9 k129.8 k162.9 k
SG&A1.4 m——1.7 m1.7 m———
Operating income-1.4 m-1.5 m-1.6 m-1.7 m-1.7 m-1.5 m-1.8 m-1.5 m
Depreciation & amortisation4.8 k5.3 k45.4 k8.5 k——5.5 k5.6 k
Interest expense3.9 k3.1 k4.7 k4.7 k3.1 k2.3 k3.4 k3.4 k
Pre-tax income-1.4 m-1.5 m-1.6 m-1.7 m-1.7 m-1.5 m-1.8 m-1.5 m
Net income-1.4 m-1.5 m-1.6 m-1.7 m-1.7 m-1.5 m-1.8 m-1.5 m
Diluted EPS-1.73-1.16 ≈-0.97-0.97-0.98-0.80 ≈-0.63-0.51
Operating cash flow-1.2 m ≈-1.4 m-1.4 m-1.6 m ≈-1.4 m ≈-1.4 m-1.6 m-1.3 m ≈
Capex23.2 k ≈3.6 k5.8 k18.7 k ≈162.8 k ≈01.8 k0 ≈

≈ 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 year20212022202320242025
Revenue90195017.1 k34.9 k14.8 k
Revenue YoYunavailable+5.4%+1,696.3%+104.5%−57.5%
Net income-620.4 k-4.7 m-8.4 m-8.4 m-6.5 m
Net income YoYunavailableunavailableunavailableunavailableunavailable
Diluted EPS-0.53-1.51-0.66-9.35-3.71
Diluted EPS YoYunavailableunavailableunavailableunavailableunavailable
net %-68,862.2%-490,630.0%-49,087.8%-24,028.2%-43,832.5%
Free cash flowunavailableunavailable-6.2 m-5.2 m-5.9 m

Reported results vs expectations

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Balance sheet & financial health

Fiscal year 2025 · 31 Dec 2025

Cash
0 USD
Financial debt
unavailable USD
Net debt
unavailable USD
Equity
7.0 m USD
Total assets
7.8 m USD
Debt / equity
unavailable
Current ratio
9.79x
ROE
-78.6%
ROA
-70.7%
FCF margin
-39,893.1%

Financial statements (source on every figure)

Revenue and net income (USD)

Margins

Income statement · USD

Revenue
2023
17.1 k
2024
34.9 k
2025
14.8 k

SEC (XBRL)· 13 Mar 2026verified

Research & development
2023
145.2 k
2024
228.0 k
2025
641.2 k

SEC (XBRL)· 13 Mar 2026verified

Operating income
2023
-7.2 m
2024
-8.4 m
2025
-6.5 m

SEC (XBRL)· 13 Mar 2026verified

Depreciation & amortisation
2023
19.2 k
2024
19.7 k
2025
65.2 k

SEC (XBRL)· 13 Mar 2026verified

EBITDA
2023
-7.2 m ≈
2024
-8.3 m ≈
2025
-6.4 m ≈

SEC (XBRL)· 13 Mar 2026derived

Interest expense
2023
6.7 m
2024
18.6 k
2025
14.8 k

SEC (XBRL)· 13 Mar 2026verified

Pre-tax income
2023
-8.4 m
2024
-8.4 m
2025
-6.5 m

SEC (XBRL)· 13 Mar 2026verified

Income tax
2023
—
2024
—
2025
—

SEC (XBRL)· 31 Mar 2023verified

Net income
2023
-8.4 m
2024
-8.4 m
2025
-6.5 m

SEC (XBRL)· 13 Mar 2026verified

Diluted EPS
2023
-0.66
2024
-9.35
2025
-3.71

SEC (XBRL)· 13 Mar 2026verified

Weighted average diluted shares
2023
12.7 m
2024
896.4 k
2025
1.8 m

SEC (XBRL)· 13 Mar 2026verified

Balance sheet · USD

Cash
2023
0
2024
0
2025
0

SEC (XBRL)· 13 Mar 2026verified

Receivables
2023
5.0 k
2024
18.6 k
2025
8.1 k

SEC (XBRL)· 13 Mar 2026verified

Current assets
2023
2.8 m
2024
8.8 m
2025
5.9 m

SEC (XBRL)· 13 Mar 2026verified

Property, plant & equipment, net
2023
571.9 k
2024
672.9 k
2025
700.1 k

SEC (XBRL)· 13 Mar 2026verified

Intangibles (excl. goodwill)
2023
21.3 k
2024
5.3 k
2025
—

SEC (XBRL)· 20 Mar 2025verified

Total assets
2023
4.5 m
2024
10.6 m
2025
7.8 m

SEC (XBRL)· 13 Mar 2026verified

Accounts payable
2023
243.2 k
2024
87.7 k
2025
97.4 k

SEC (XBRL)· 13 Mar 2026verified

Current liabilities
2023
841.1 k
2024
631.7 k
2025
604.8 k

SEC (XBRL)· 13 Mar 2026verified

Total liabilities
2023
1.5 m
2024
1.1 m
2025
793.1 k

SEC (XBRL)· 13 Mar 2026verified

Equity
2023
3.0 m †
2024
9.6 m †
2025
7.0 m †

SEC (XBRL)· 13 Mar 2026verified

Cash flow · USD

Operating cash flow
2023
-5.7 m
2024
-5.0 m
2025
-5.7 m

SEC (XBRL)· 13 Mar 2026verified

Capex
2023
575.7 k
2024
214.8 k
2025
187.3 k

SEC (XBRL)· 13 Mar 2026verified

Free cash flow
2023
-6.2 m ≈
2024
-5.2 m ≈
2025
-5.9 m ≈

SEC (XBRL)· 13 Mar 2026derived

Investing cash flow
2023
-794.3 k
2024
-404.2 k
2025
-419.3 k

SEC (XBRL)· 13 Mar 2026verified

Financing cash flow
2023
3.6 m
2024
11.9 m
2025
3.4 m

SEC (XBRL)· 13 Mar 2026verified

Computed indicators

Growth

Revenue growth (YoY)
-57.5%
computed by olivLawFY 2025
Revenue CAGR 3Y
149.9%
computed by olivLawFY 2022 → FY 2025
Revenue CAGR 5Y
unavailable
input data missing
EBIT growth (YoY)
unavailable
the base of the ratio is not positive
Net income growth (YoY)
unavailable
the base of the ratio is not positive
Net income CAGR 3Y
unavailable
the base of the ratio is not positive
Net income CAGR 5Y
unavailable
input data missing
EPS growth (YoY)
unavailable
the base of the ratio is not positive
EPS CAGR 3Y
unavailable
the base of the ratio is not positive
EPS CAGR 5Y
unavailable
input data missing
FCF growth (YoY)
unavailable
the base of the ratio is not positive

Profitability

Gross margin
unavailable
input data missing
EBITDA margin
-44,535.4%
computed by olivLawTTM to 30 Jun 2026
EBIT margin
-44,690.7%
computed by olivLawTTM to 30 Jun 2026
Net margin
-44,771.8%
computed by olivLawTTM to 30 Jun 2026
FCF margin
-40,307.5%
computed by olivLawTTM to 30 Jun 2026

Returns

ROE
-75.4%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
ROA
-70.6%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
ROIC
unavailable
input data missing
ROCE
-85.3%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
Payout ratio (EPS)
unavailable
input data missing
Payout ratio (FCF)
unavailable
input data missing

Balance sheet

Net debt
unavailable
input data missing
Net debt / EBITDA
unavailable
input data missing
Debt / equity
unavailable
input data missing
Interest coverage
-525.1x
computed by olivLawTTM to 30 Jun 2026

Liquidity

Current ratio
17.1x
computed by olivLawbalance sheet at 30 Jun 2026
Quick ratio
unavailable
input data missing
Cash ratio
0.0x
computed by olivLawbalance sheet at 30 Jun 2026

Cash

Operating cash flow
-5.7 m USD
computed by olivLawTTM to 30 Jun 2026
Capital expenditure
164.6 k USD
computed by olivLawTTM to 30 Jun 2026
Free cash flow
-5.8 m USD
computed by olivLawTTM to 30 Jun 2026
FCF conversion
unavailable
insufficient data
Cash conversion
unavailable
insufficient data

Efficiency

Days sales outstanding
213 days
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
Days inventory outstanding
unavailable
input data missing
Days payables outstanding
unavailable
input data missing
Cash conversion cycle
unavailable
input data missing

Market and valuation

Market capitalisation
4.9 m USD
computed by olivLawbalance sheet at 30 Jun 2026
Enterprise value
unavailable
input data missing
Market cap / net income TTM
unavailable
insufficient data
P/E (TTM)
unavailable
insufficient data
Earnings yield
-177.8%
computed by olivLawTTM to 30 Jun 2026
P/B
0.7x
computed by olivLawbalance sheet at 30 Jun 2026
P/S
336.9x
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
EV/EBITDA
unavailable
input data missing
EV/EBIT
unavailable
input data missing
EV/Sales
unavailable
input data missing
P/FCF
unavailable
the base of the ratio is not positive
FCF yield
-119.6%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
Dividend yield
unavailable
no dividend in the structured statements; a missing line is not a confirmed zero
Shareholder yield (distributions)
unavailable
input data missing

1 indicators that do not apply to the sector.

Valuation

olivLaw classification

Insufficient data
What is missing
  • indicators available: 5 of at least 6
  • score weight coverage: 33.3% of at least 60%
  • valuation methods computed: 0 of at least 1

A scoring methodology on indicators and valuation, not investment advice.

Closing price

1.65 USD

04 Nov 2026Source: olivLaw, closing series

Market cap: 4.9 m USD

Key indicators

Market capitalisation
4.9 m USD
computed by olivLawbalance sheet at 30 Jun 2026
P/E (TTM)
unavailable
insufficient data
P/B
0.7x
computed by olivLawbalance sheet at 30 Jun 2026
EV/EBITDA
unavailable
input data missing
ROE
-75.4%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
Net margin
-44,771.8%
computed by olivLawTTM to 30 Jun 2026
Revenue growth (YoY)
-57.5%
computed by olivLawFY 2025
Dividend yield
unavailable
no dividend in the structured statements; a missing line is not a confirmed zero

Coverage and freshness

26/37 reporting lines present
Latest full fiscal year: 2025
Latest reported period: 30 Jun 2026
Latest balance sheet date: 30 Jun 2026
Share count (cover of the latest filing), as of: 07 Aug 2026
Source: SEC (XBRL)published 07 Aug 2026
verified 601derived 42

Score by group

33% · 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 · net debt missing: EV cannot be bridged to equity (missing debt is not zero)
  • 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

Multiple comparisons use the SIC vertical: In Vitro & In Vivo Diagnostic Substances (SIC 2835)

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: 5 of at least 6; score weight coverage: 33.3% of at least 60%; valuation methods computed: 0 of at least 1

FactorValueScoreWeight used
ROIC · Qualityunavailableunavailable—
Net margin · Quality-44,771.8%13 (vs peers)19%
FCF conversion · Qualityunavailableunavailable—
Revenue CAGR 3Y · Growth149.9%100 (on a fixed band)25%
EPS CAGR 3Y · Growthunavailableunavailable—
Net debt / EBITDA · Balance sheetunavailableunavailable—
Interest coverage · Balance sheet-525.1x0 (on a fixed band)19%
Current ratio · Balance sheet17.1x100 (on a fixed band)13%
P/E (TTM) · Valuationunavailableunavailable—
EV/EBITDA · Valuationunavailableunavailable—
FCF yield · Valuation-119.6%0 (on a fixed band)25%
Shareholder yield (distributions) · Returnsunavailableunavailable—
Payout ratio (FCF) · Returnsunavailableunavailable—

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
  • Quality· partial13/100 · 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

Cardio Diagnostics Holdings, Inc. (CDIO). Latest full fiscal year: 2025; data up to 2026-06-30.

Figures computed from the financial statements: revenue 14.8 k USD in 2025; YoY growth -57.5%; net margin -44,771.8%; ROE -75.4%.

Valuation cannot be computed from the available data.

Insufficient data for a verdict (indicators available: 5 of at least 6; score weight coverage: 33.3% 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: 149.9%
  • Current ratio: 17.1x

What contradicts it

  • Net margin: -44,771.8%
  • Interest coverage: -525.1x
  • FCF yield: -119.6%

Not assessed (insufficient data or a ratio without meaning): ROIC, FCF conversion, EPS CAGR 3Y, Net debt / EBITDA, P/E (TTM), EV/EBITDA, Shareholder yield (distributions), Payout ratio (FCF).

Versus the vertical median

In Vitro & In Vivo Diagnostic Substances (SIC 2835) · same industry (4-digit SIC) · compared with 17 companies

Multiples and returns vs the median

P/E
—
vertical median 36.1x
EV/EBITDA
—
vertical median 15.4x
P/S
336.9x
vertical median 6.6x
above median (+4,967.7%)
P/B
0.7x
vertical median 2.3x
below median (−71.2%)
ROE
-75.4%
vertical median -28.4%
below median
Net margin
-44,771.8%
vertical median -38.4%
below median
EBIT margin
-44,690.7%
vertical median -34.4%
below median
Revenue YoY
-57.5%
vertical median 2.4%
below median (−2,473.3%)
Net debt/EBITDA
—
vertical median 0.1x
Dividend yield
—
vertical median —

Price rebased to 100 (monthly, 5 years)

Companies in the vertical

Market capP/EROENet marginRevenue YoY1A / 3A
IDXXIdexx Laboratories Inc55.0 bn47.168.9%25.4%+10.4%−7% / +50%
LNTHLantheus Holdings, Inc.6.6 bn24.522.2%17.7%+0.5%+72% / +41%
NEOGNeogen Corporation2.7 bn—-2.7%-6.3%−2.7%+108% / −27%
TRIBTrinity Biotech PLC2.4 bn——-51.6%+8.3%−80% / −91%
CLDXCelldex Therapeutics, Inc.2.4 bn—-43.9%-190,220.9%−78.0%+11% / −1%
NTLAIntellia Therapeutics, Inc.1.7 bn—-6,424.8%-672.2%+16.9%+37% / −58%
QDELQuidelortho Corp984.6 m—-19.3%-14.2%−1.9%−48% / −79%
ACHVAchieve Life Sciences, Inc.718.3 m—-845.0%—unavailable+43% / +21%
MYGNMyriad Genetics, Inc.575.8 m—-32.5%-14.0%−1.6%−21% / −68%
TKNOAlpha Teknova, Inc.395.7 m—-24.2%-38.4%+7.4%+57% / +261%
ICCCImmuCell Corporation94.2 m138.22.6%2.6%+4.3%+114% / +128%
IMDXInsight Molecular Diagnostics Inc.86.7 m——-2,955.6%+115.6%−57% / −30%
BMRABiomerica, Inc.8.0 m—-113.8%-115.5%−16.2%−27% / −77%
CDIOCardio Diagnostics Holdings, Inc.4.9 m—-75.4%-44,771.8%−57.5%−55% / −85%
QCLSQ/C Technologies, Inc.3.2 m—-155.0%—−5.3%−89% / −100%
VNRXVolitionRx Limited2.8 m——-1,043.1%+40.0%−97% / −99%
VRAXVirax Biolabs Group Ltd695.1 k—-109.6%-95,739.2%−96.0%−88% / −98%
NNNNAnbio Biotechnology—25.027.0%74.1%+5.6%−84% / unavailable

1- and 3-year price returns: for CDIO 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.

Bear
Allowed range: -50 … 50%
Allowed range: -100 … 100%
Allowed range: 0 … 100
Allowed range: -10 … 20%
Allowed range: 0 … 100%
Base
Allowed range: -50 … 50%
Allowed range: -100 … 100%
Allowed range: 0 … 100
Allowed range: -10 … 20%
Allowed range: 0 … 100%
Bull
Allowed range: -50 … 50%
Allowed range: -100 … 100%
Allowed range: 0 … 100
Allowed range: -10 … 20%
Allowed range: 0 … 100%
Nothing is saved.

Estimated price (USD)

Estimated priceBearBaseBull
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
What moves the 3-year price the most

    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

    Cardio Diagnostics Holdings develops and sells clinical blood tests for cardiovascular disease, built on epigenetics and an AI platform called the Multi-Omics Engine. The company is still at an early stage, with very small revenue and continuing losses, and its expansion depends largely on winning payer reimbursement, a process that can take years 12.

    SWOT

    Strengths

    • A portfolio of clinical tests with CPT PLA codes and a set CMS payment rate.
    • A proprietary AI platform built over several years of research.
    • An in-house CLIA laboratory that reduces reliance on third parties.

    Weaknesses

    • Very small revenue and continuing net losses over the past two years.
    • Funding that depends on equity sales under the at-the-market program.
    • Long sales and partnership cycles, sometimes exceeding two years.

    Opportunities

    • Wider reimbursement from Medicare and other commercial payers.
    • Development of new tests for stroke, heart failure and diabetes.
    • International expansion, starting with India.

    Threats

    • A slow pace of payer coverage could limit growth.
    • Dilution of shareholders from equity-based financing.
    • Economic pressure could slow prevention budgets.

    Risks

    • Negligible revenuehigh

      The company has reported very small revenue and has not yet reached profitability, and it may never do so 1.

    • Need for additional capitalhigh

      The company relies on at-the-market equity sales, and if it cannot raise funds it could scale back operations 1.

    • Uncertain reimbursementmedium

      Without broad payer coverage, test volume could remain limited, and the process may take years 12.

    • Dilutionmedium

      Share issuances may reduce the stake of existing shareholders and may carry liquidation preferences 1.

    • Regulatory changelow

      Although the LDT rule was rescinded, a future FDA framework or other regulation could change operating conditions 1.

    Investment thesis

    What would need to be true (bull case)

    • If payer coverage widens, the existing tests could generate much higher volume without a proportional rise in costs.
    • The in-house CLIA laboratory and the first covered commercial payer could strengthen the company's position in the US.
    • International expansion and new tests could diversify revenue sources if execution succeeds.

    What would break the thesis

    • Revenue is close to nonexistent, and continuing losses could use up available capital before sales grow.
    • Reliance on equity financing could heavily dilute existing shareholders.
    • Long reimbursement cycles could delay meaningful revenue by years.

    What to watch

    • Revenue trend and expansion of commercial payer coverageQ3 2026
    • New York license approval and test volume2026
    • Progress on Medicare coveragenext 10-K
    • India implementation and regular shipments2027

    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

    Cardio was formed to develop and commercialize products for major types of cardiovascular disease and associated comorbidities, including coronary heart disease, stroke, heart failure and diabetes 1. Its first tests are Epi+Gen CHD, launched in 2021, and PrecisionCHD, launched in March 2023, both categorized as laboratory-developed tests 1. Revenue was nominal: $14,825 in 2025, compared with $34,890 in 2024, mainly because a heart attack prevention testing initiative with Family Medicine Specialists concluded 1. By June 2026 the company had begun testing patient samples in its new high complexity CLIA laboratory, which could reduce cost of goods sold if volume grows 2.

    Segments

    Clinical blood tests

    Epi+Gen CHD and PrecisionCHD are epigenetic-genetic tests for coronary heart disease risk assessment and detection. The company has secured CPT PLA codes and CMS gapfill payment rates of $854 per test 1. The first commercial payer to cover them is a California independent physician association, with coverage from May 2026 2.

    HeartRisk platform

    HeartRisk is a cardiovascular disease risk intelligence platform aimed at employers and benefit brokers, providing population-level, de-identified aggregated data 2. It is designed to complement the blood tests rather than replace them 1.

    Market context

    The company cites a global cardiovascular diagnostic testing market estimated at $8.47 billion in 2022, projected to grow to $12.41 billion by 2027 at a CAGR of 7.94% 1. Cardiovascular disease costs in the United States were $555 billion in 2016 and are projected to exceed $1 trillion by 2035 1. If demand for early prevention keeps growing, the market could become more receptive to products like Cardio's 1.

    Trends

    • Aging populationtailwind

      The number of Americans aged 65 and over is projected to grow substantially by 2060, which could increase demand for cardiovascular diagnostics 1.

    • Shift to value-based caretailwind

      Quality-based payment models may encourage providers to prevent costly events, which could favor early testing 1.

    • FDA withdrawal from LDT regulationmixed

      In September 2025 the FDA rescinded its May 2024 rule on laboratory-developed tests, returning oversight to CLIA 1. This reduces regulatory uncertainty but does not remove the need for reimbursement.

    • Long reimbursement cyclesheadwind

      Securing coverage from Medicare and commercial payers can take years, which limits meaningful revenue in the meantime 12. If the process accelerates, the impact could turn positive.

    Competitive position

    The provided sources do not name any US-listed competitors, so the profile cannot identify competing companies with certainty. The company differentiates itself through its epigenetic evidence base and by combining clinical tests with data products for employers 1. Direct competition could come from laboratories offering similar cardiovascular tests, though these are not described in the source documents.

    • Cardiovascular diagnostic laboratories (not named in sources)

      The source documents do not name specific competitors; this is a general category.

    • Genetic and epigenetic testing providers

      Not named in the provided sources; they could compete for the same payers and providers.

    • Channel partners and reimbursement gatekeepers

      Not direct competitors, but they influence market access.

    • Employer risk analytics platforms

      Not named in the sources; they could compete with HeartRisk for benefit budgets.

    News & filings

    In the press

    SEC filings

    Sources

    1. [1] Form 10-K, fiscal year ended 2025-12-31 · SEC / Cardio Diagnostics Holdings, Inc. · 13 Mar 2026
    2. [2] Form 10-Q, quarter ended 2026-06-30 · SEC / Cardio Diagnostics Holdings, Inc. · 07 Aug 2026

    Figures computed by olivLaw from SEC filings and closing prices; the qualitative analysis is AI-generated from cited sources. Not investment advice.