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olivLaw · European equity research

Sedana Medical AB (publ) SEDANA.ST

Sweden · Nasdaq Stockholm · ISIN SE0015988373 · Vertical: Listed companies from Sweden

9.69SEK+1.47% · 1 dayClose 05 Nov 2026

Sedana Medical develops and sells the Sedaconda ACD device and isoflurane for inhalation sedation of mechanically ventilated intensive care patients, with net sales rising 12 percent in 2025 to 200 226 KSEK. The company is preparing a US marketing application around mid-2026, which makes this period decisive.

At the close of 05 Nov 2026, Sedana Medical AB (publ) (SEDANA.ST) stock was 9.69 SEK (+1.47% on the day), with market capitalisation 956.8 m SEK, beta 1.04, 52-week range 7.93–13.62 SEK.

Data as of · AI analysis dated · Source: ESEF annual reports and closing prices, computed by olivLaw.

Market cap
956.8 m SEK
shares as of 31 Dec 2025
P/E (TTM)
unavailable
Diluted EPS TTM -0.60 · TTM to 31 Dec 2025
E/P (TTM)
-6.19%
TTM to 31 Dec 2025
Dividend yield
unavailable
Beta (2y)
1.04
Volatility (1y) 51%
52-week range
7.9313.62

Price history

Loading chart…

Technical reading

RSI (14)
50.4
neutral
Bollinger (20, 2)
9.08 – 10.07
in the upper half of the band · %B 0.62 · band width 10.3%
SMA 50 / 200
10.03 / 9.64
mixed trend
MACD (12, 26, 9)
-0.13 / -0.16
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

CompanyEURO STOXX 50vs EURO STOXX 50Vertical median
1 month−2.3%−0.6%−1.7 pp—
3 months−5.7%−4.2%−1.6 pp—
6 months−0.8%+4.3%−5.2 pp—
Year to date−5.7%+7.5%−13.2 pp—
1 year−1.9%+9.9%−11.8 pp−8.5%
3 years−51.7%+49.8%−101.6 pp+12.3%
5 years−89.7%+42.8%−132.5 pp—
Max drawdown (1y)
−34.0%
27 Aug 2026 → 28 Oct 2026
Max drawdown (5y)
−93.0%
30 Dec 2021 → 07 Apr 2025
Compound annual growth (5y)
−36.5%
EURO STOXX 50 +7.4%

Price returns, dividends excluded.

Quarterly results

ESEF annual reports carry no quarters: the results are annual (below).

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 year202320242025
Revenue153.9 m178.8 m200.2 m
Revenue YoYunavailable+16.2%+12.0%
Net income-59.6 m-10.7 m-59.2 m
Net income YoYunavailableunavailableunavailable
Diluted EPS-0.60-0.11-0.60
Diluted EPS YoYunavailableunavailableunavailable
net %-38.7%-6.0%-29.6%
Free cash flow-38.6 m-14.0 m-15.2 m

Balance sheet & financial health

Fiscal year 2025 · 31 Dec 2025

Cash
91.0 m SEK
Financial debt
unavailable SEK
Net debt
unavailable SEK
Equity
900.8 m SEK
Total assets
954.5 m SEK
Debt / equity
unavailable
Current ratio
3.40x
ROE
-6.4%
ROA
-6.0%
FCF margin
-7.6%

Financial statements (source on every figure)

Revenue and net income (SEK)

Margins

Income statement · SEK

Revenue
2023
153.9 m
2024
178.8 m
2025
200.2 m

esef· 26 Oct 2026verified

Cost of revenue
2023
44.9 m
2024
52.6 m
2025
57.5 m

esef· 26 Oct 2026verified

Gross profit
2023
109.0 m
2024
126.1 m
2025
142.7 m

esef· 26 Oct 2026verified

Research & development
2023
20.8 m
2024
20.3 m
2025
20.6 m

esef· 26 Oct 2026verified

Operating income
2023
-65.5 m
2024
-52.2 m
2025
-32.2 m

esef· 26 Oct 2026verified

Interest expense
2023
9.3 m
2024
22.5 m
2025
28.5 m

esef· 26 Oct 2026verified

Pre-tax income
2023
-59.0 m
2024
-9.9 m
2025
-57.3 m

esef· 26 Oct 2026verified

Income tax
2023
593.0 k
2024
726.0 k
2025
2.0 m

esef· 26 Oct 2026verified

Net income
2023
-59.6 m
2024
-10.7 m
2025
-59.2 m

esef· 26 Oct 2026verified

Diluted EPS
2023
-0.60
2024
-0.11
2025
-0.60

esef· 26 Oct 2026verified

Balance sheet · SEK

Cash
2023
231.2 m
2024
194.0 m
2025
91.0 m

esef· 26 Oct 2026verified

Inventories
2023
43.0 m
2024
45.6 m
2025
37.9 m

esef· 26 Oct 2026verified

Current assets
2023
459.6 m
2024
278.2 m
2025
173.8 m

esef· 26 Oct 2026verified

Goodwill
2023
0
2024
26.6 m
2025
25.3 m

esef· 26 Oct 2026verified

Total assets
2023
1.0 bn
2024
1.0 bn
2025
954.5 m

esef· 26 Oct 2026verified

Current liabilities
2023
43.0 m
2024
51.6 m
2025
51.0 m

esef· 26 Oct 2026verified

Total liabilities
2023
44.1 m
2024
61.2 m
2025
53.7 m

esef· 26 Oct 2026verified

Equity
2023
970.0 m
2024
958.2 m
2025
900.8 m

esef· 26 Oct 2026verified

Shares outstanding at year end
2023
99.4 m
2024
97.0 m
2025
98.7 m

esef· 26 Oct 2026derived

Cash flow · SEK

Operating cash flow
2023
-38.1 m
2024
-11.8 m
2025
-12.8 m

esef· 26 Oct 2026verified

Capex
2023
515.0 k
2024
2.2 m
2025
2.4 m

esef· 26 Oct 2026verified

Free cash flow
2023
-38.6 m ≈
2024
-14.0 m ≈
2025
-15.2 m ≈

esef· 26 Oct 2026derived

Investing cash flow
2023
-322.0 m
2024
-44.7 m
2025
-63.0 m

esef· 26 Oct 2026verified

Financing cash flow
2023
-4.9 m
2024
-3.6 m
2025
-4.0 m

esef· 26 Oct 2026verified

Computed indicators

Growth

Revenue growth (YoY)
12.0%
computed by olivLawFY 2025
Revenue CAGR 3Y
unavailable
input data missing
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
input data missing
Net income CAGR 5Y
unavailable
input data missing
EPS growth (YoY)
unavailable
the base of the ratio is not positive
EPS CAGR 3Y
unavailable
input data missing
EPS CAGR 5Y
unavailable
input data missing
FCF growth (YoY)
unavailable
the base of the ratio is not positive

Profitability

Gross margin
71.3%
computed by olivLawFY 2025
EBITDA margin
unavailable
input data missing
EBIT margin
-16.1%
computed by olivLawFY 2025
Net margin
-29.6%
computed by olivLawFY 2025
FCF margin
-7.6%
computed by olivLawFY 2025

Returns

ROE
-6.4%
computed by olivLawFY 2025 · balance sheet at 31 Dec 2025
ROA
-6.0%
computed by olivLawFY 2025 · balance sheet at 31 Dec 2025
ROIC
unavailable
input data missing
ROCE
-3.6%
computed by olivLawFY 2025 · balance sheet at 31 Dec 2025
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
-1.1x
computed by olivLawFY 2025

Liquidity

Current ratio
3.4x
computed by olivLawbalance sheet at 31 Dec 2025
Quick ratio
2.7x
computed by olivLawbalance sheet at 31 Dec 2025
Cash ratio
1.8x
computed by olivLawbalance sheet at 31 Dec 2025

Cash

Operating cash flow
-12.8 m SEK
computed by olivLawFY 2025
Capital expenditure
2.4 m SEK
computed by olivLawFY 2025
Free cash flow
-15.2 m SEK
computed by olivLawFY 2025
FCF conversion
unavailable
insufficient data
Cash conversion
unavailable
input data missing

Efficiency

Days sales outstanding
unavailable
input data missing
Days inventory outstanding
265 days
computed by olivLawFY 2025 · balance sheet at 31 Dec 2025
Days payables outstanding
unavailable
input data missing
Cash conversion cycle
unavailable
input data missing

Market and valuation

Market capitalisation
956.8 m SEK
computed by olivLawbalance sheet at 31 Dec 2025
Enterprise value
unavailable
input data missing
Market cap / net income TTM
unavailable
insufficient data
P/E (TTM)
unavailable
insufficient data
Earnings yield
-6.2%
computed by olivLawFY 2025
P/B
1.1x
computed by olivLawbalance sheet at 31 Dec 2025
P/S
4.8x
computed by olivLawFY 2025 · balance sheet at 31 Dec 2025
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
-1.6%
computed by olivLawFY 2025 · balance sheet at 31 Dec 2025
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: 4 of at least 6
  • score weight coverage: 25.0% of at least 60%
  • valuation methods computed: 0 of at least 1

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

Closing price

9.69 SEK

05 Nov 2026Source: olivLaw, closing series

Market cap: 956.8 m SEK

Key indicators

Market capitalisation
956.8 m SEK
computed by olivLawbalance sheet at 31 Dec 2025
P/E (TTM)
unavailable
insufficient data
P/B
1.1x
computed by olivLawbalance sheet at 31 Dec 2025
EV/EBITDA
unavailable
input data missing
ROE
-6.4%
computed by olivLawFY 2025 · balance sheet at 31 Dec 2025
Net margin
-29.6%
computed by olivLawFY 2025
Revenue growth (YoY)
12.0%
computed by olivLawFY 2025
Dividend yield
unavailable
no dividend in the structured statements; a missing line is not a confirmed zero

Coverage and freshness

24/37 reporting lines present
Latest full fiscal year: 2025
Latest reported period: 31 Dec 2025
Latest balance sheet date: 31 Dec 2025
Share count (cover of the latest filing), as of: 31 Dec 2025
Source: esefpublished 26 Oct 2026
verified 74derived 3

Score by group

25% · Insufficient data

Estimated value range

unavailable — no valuation assumptions for the reporting currency

Valuation assumptions are editorial choices, not measured; beta is not measured.

Valuation methods

    Assumptions (illustrative, editorial)

    Risk-free rate
    6.5%
    Equity risk premium
    6.0%
    Beta (default)
    1.00
    Cost of equity
    12.5%
    Terminal growth
    3.0%

    Factor scorecard

    Insufficient data

    Minimum-evidence gate: indicators available: 4 of at least 6; score weight coverage: 25.0% of at least 60%; valuation methods computed: 0 of at least 1

    FactorValueScoreWeight used
    ROIC · Qualityunavailableunavailable—
    Net margin · Quality-29.6%8 (vs peers)25%
    FCF conversion · Qualityunavailableunavailable—
    Revenue CAGR 3Y · Growthunavailableunavailable—
    EPS CAGR 3Y · Growthunavailableunavailable—
    Net debt / EBITDA · Balance sheetunavailableunavailable—
    Interest coverage · Balance sheet-1.1x0 (on a fixed band)25%
    Current ratio · Balance sheet3.4x100 (on a fixed band)17%
    P/E (TTM) · Valuationunavailableunavailable—
    EV/EBITDA · Valuationunavailableunavailable—
    FCF yield · Valuation-1.6%0 (on a fixed band)33%
    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· partialunavailable · 0/2 factors with a value
    • Quality· partial8/100 · 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

    Sedana Medical AB (publ) (SEDANA.ST). Latest full fiscal year: 2025; data up to 2025-12-31.

    Figures computed from the financial statements: revenue 200.2 m SEK in 2025; YoY growth 12.0%; net margin -29.6%; ROE -6.4%.

    Valuation cannot be computed from the available data.

    Insufficient data for a verdict (indicators available: 4 of at least 6; score weight coverage: 25.0% of at least 60%; valuation methods computed: 0 of at least 1).

    Text generated deterministically from the figures shown; no language model. Not investment advice.

    What supports the thesis

    • Current ratio: 3.4x

    What contradicts it

    • Net margin: -29.6%
    • Interest coverage: -1.1x
    • FCF yield: -1.6%

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

    Versus the vertical median

    Listed companies from Sweden · same country · compared with 39 companies

    Multiples and returns vs the median

    P/E
    —
    vertical median 22.9x
    EV/EBITDA
    —
    vertical median 5.3x
    P/S
    4.8x
    vertical median 1.1x
    above median (+326.9%)
    P/B
    1.1x
    vertical median 1.4x
    below median (−22.6%)
    ROE
    -6.4%
    vertical median 7.4%
    below median (−186.3%)
    Net margin
    -29.6%
    vertical median 4.3%
    below median (−788.3%)
    EBIT margin
    -16.1%
    vertical median 6.0%
    below median (−367.2%)
    Revenue YoY
    12.0%
    vertical median 1.3%
    above median (+799.0%)
    Net debt/EBITDA
    —
    vertical median 1.5x
    Dividend yield
    —
    vertical median 2.5%

    Price rebased to 100 (monthly, 5 years)

    Companies in the vertical

    Market capP/EROENet marginRevenue YoY1A / 3A
    ALFA.STAlfa Laval AB223.0 bn27.019.4%11.9%+4.1%+21% / +38%
    BOL.STBoliden Ab143.0 bn15.213.3%10.1%+4.8%+12% / +81%
    CAST.STCastellum Aktiebolag66.6 bn71.01.2%9.8%−2.6%+27% / +6%
    AAK.STAak Ab (publ)47.5 bn13.917.2%7.5%+2.2%−31% / −14%
    CAMX.STCamurus AB42.5 bn58.519.5%32.5%+21.3%+16% / +55%
    BRAV.STBravida Holding AB30.1 bn24.513.7%4.4%−4.9%+84% / +123%
    ASKER.STAsker Healthcare Group AB29.8 bn60.59.8%2.9%+11.7%−18% / unavailable
    ALLEI.STAlleima AB22.7 bn33.84.1%3.6%−5.4%+11% / +19%
    BURE.STBure Equity AB22.6 bn—-21.0%—unavailable+20% / +19%
    AQ.STAQ Group AB19.7 bn29.214.9%7.5%+6.0%+14% / +119%
    ALTRA.STAltra Fastigheter AB18.4 bn33.93.0%15.1%−2.2%+9% / +19%
    ATT.STAttendo AB (publ)16.8 bn20.715.1%4.3%+0.1%+34% / +223%
    AFRY.STAfry Ab14.9 bn18.76.2%3.1%−5.2%−17% / +4%
    ATRLJ-B.STAtrium Ljungberg AB14.0 bn17.12.9%23.9%−2.0%−33% / −44%
    ALIG.STAlimak Group AB (publ)12.7 bn21.38.2%8.8%−3.2%−18% / +50%
    ACAD.STAcadeMedia AB12.7 bn15.512.7%4.3%+9.7%+22% / +138%
    APOTEA.STApotea AB (publ)10.7 bn46.831.3%3.2%+10.1%+15% / unavailable
    BOOZT.STBoozt AB10.6 bn37.910.4%3.6%+0.5%+58% / +44%
    BUFAB.STBufab AB (publ)5.0 bn9.215.1%6.9%−7.4%+36% / +110%
    ACTI.STActive Biotech AB (publ)4.9 bn—-84.5%—unavailable−32% / −77%
    CEVI.STCellaVision AB4.7 bn30.818.0%20.2%+4.9%+20% / +12%
    COOR.STCoor Service Management Holding AB4.7 bn18.213.0%2.2%+16.7%+1% / +25%
    BHG.STBHG Group AB4.5 bn31.12.5%1.4%+6.2%−18% / +113%
    CARA.STCarasent AB (publ)1.8 bn51.74.1%10.1%+24.9%−8% / +87%
    BICO.STBICO Group AB1.7 bn—-46.0%-72.7%−13.3%+16% / −51%

    1- and 3-year price returns: for SEDANA.ST 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 (SEK)

    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

      Sedana Medical develops and sells the Sedaconda ACD device and isoflurane for inhalation sedation of mechanically ventilated intensive care patients, with net sales rising 12 percent in 2025 to 200 226 KSEK 1. The company is preparing a US marketing application around mid-2026, which makes this period decisive.

      SWOT

      Strengths

      • The product has patent protection and data exclusivity in Europe, which limits direct competition in inhalation sedation.
      • The company already has profitable activity outside the US, giving it a financial base for international launches.
      • The device works with existing intensive care equipment without new investment, which eases adoption.

      Weaknesses

      • The company depends heavily on a small number of products and a single therapy, so setbacks in studies would have a major impact.
      • The company has significant accumulated tax losses, and their use may be limited by changes of ownership.
      • Results are reported in SEK while much of the cost and revenue base is in euro, exposing the company to currency fluctuations.

      Opportunities

      • US approval could open the company's largest market, with launch planned for 2027 if the FDA approves the application.
      • If inhalation sedation spreads in intensive care, the company could gain market share from intravenous sedation.
      • The Early Access Program approved by the FDA could bring first clinical experience in the US before full approval.

      Threats

      • The US marketing application could be delayed or rejected, postponing the launch and related revenue.
      • Pressure on hospital budgets may reduce willingness to pay for new products, including the company's.
      • Stricter rules for medical devices and medicines may raise compliance costs and slow launches.

      Risks

      • US regulatory approvalhigh

        Success in the US market depends on the FDA accepting the marketing application, and a rejection would postpone the planned launch.

      • Results of clinical studieshigh

        If clinical studies were negative or insufficient, the necessary approvals could be missing and revenue would be significantly affected.

      • Dependence on few productshigh

        The company's strategy rests on one technology and one therapy, so any problem would have a major impact on the whole business.

      • Currency riskmedium

        A significant part of revenue and costs is in euro while reporting is in SEK, which can produce losses from exchange rates.

      Investment thesis

      What would need to be true (bull case)

      • If US approval follows on the planned timeline, the 2027 launch could significantly expand the company's market.
      • Data exclusivity in Europe and patented technology provide an entry barrier for potential direct competitors.
      • The economic and clinical arguments for inhalation sedation, supported by external recommendations, could accelerate adoption in intensive care.

      What would break the thesis

      • The US marketing application is an uncertain step, and a rejection or delay could considerably slow the company's growth.
      • Intravenous sedation remains the established standard, and changing clinical habits can be slow and costly.
      • The business depends on a small number of products, and weakness in the European market, such as in Germany, could weigh on results.

      What to watch

      • Submission of the NDA to the FDAmid-2026
      • FDA decision on approval and US launch2027
      • Sales development in Germany and other European marketsnext quarterly report
      • Early results from the US Early Access Program patients2026

      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

      Sedana Medical AB is a Swedish company whose main product is the Sedaconda ACD system, a single-use medical device that administers volatile anaesthetics during mechanical ventilation and recirculates them to the patient, combined with Sedaconda isoflurane. According to the annual report, the company relies on patented technology that combines vaporisation, filtration and humidification in one device, compatible with equipment already in intensive care units 1. Revenue comes largely from outside the US, and the company had 112 employees at year-end 2025 1.

      The business model rests on the idea that inhalation sedation can reduce intensive care stays and associated costs, and the report cites the UK NICE recommendation as an economic alternative 1. The company does not aim to sell new equipment but a product that works with hardware already present in hospitals, which lowers adoption barriers 1.

      For the US, the company plans to launch its products in-house with its own sales force if the FDA approves the application, with launch planned for 2027 1. An Early Access Program was approved by the FDA in April 2025, and the first patient was treated in March 2026 1.

      Segments

      Sedaconda ACD and Sedaconda isoflurane

      The core segment combines the Sedaconda ACD medical device with the isoflurane medicine, sold as an inhalation sedation therapy in intensive care. The company states that data exclusivity for Sedaconda isoflurane in Europe runs until 2032, making it the only company authorised to market inhalation sedation in intensive care in that region 1.

      Production and acquisitions

      After acquiring Innovatif Cekal in 2024, the company gained direct control over a larger share of material costs and production capacity at the supplier of its main product 1. This integration may improve cost and supply chain control but also adds operational responsibilities.

      Market context

      The target market is sedation of mechanically ventilated intensive care patients, where the report cites roughly eight million patients sedated annually worldwide, usually for two to five days 1. Intravenous sedation with propofol and benzodiazepines remains the standard, and its limitations leave room for growth in inhalation sedation, although the report acknowledges that adoption depends on several factors 1.

      In the European market the company already operates profitably outside the US, and Germany is an important market, where sales grew strongly in the first half of 2025 and were then hit negatively in the second half 1. Progress in the US remains conditional on FDA approval.

      Trends

      • FDA approval for the US markettailwind

        The company plans an NDA submission around mid-2026 based on the INSPiRE-ICU studies, and the FDA has confirmed the data appear sufficient for submission 1. If approval follows, the US launch could open the company's largest market.

      • Cost and efficiency in intensive caretailwind

        Cost pressure on intensive care budgets may favour solutions that shorten patient stays, and inhalation sedation is presented as offering economic and clinical advantages 1. This context could support adoption of the product.

      • Regulation and compliance requirementsheadwind

        Regulation of medical devices and medicines is becoming stricter, and compliance costs can be high; MDR and MDD certificates must be renewed periodically 1. These requirements could slow or raise the cost of launches.

      • Sustainability and medical practicemixed

        The company argues that inhalation sedation shortens intensive care stays and therefore the associated emissions, which may matter to hospitals pursuing environmental targets 1. However, positioning depends on clinical evidence and acceptance by the health system.

      Competitive position

      The main competition is intravenous sedation, a well-established standard therapy in intensive care, and the company acknowledges it must win market share from it 1. There is also a risk of direct competition within the inhalation sedation indication if other suppliers enter this market 1.

      The company differentiates itself through data exclusivity for Sedaconda isoflurane in Europe and because the product works with existing equipment without new hardware investment 1. The report does not name specific competitors, so the list below stays limited to the categories presented in the source.

      • Intravenous sedation drugs (propofol, benzodiazepines)

        The standard therapy in intensive care, described in the report as the main competitor to inhalation sedation.

      • Other inhalation sedation suppliers

        The report mentions the risk of competition emerging in the inhalation sedation indication, without naming firms.

      • Alternative sedation systems in intensive care

        The risk of not gaining market acceptance against existing alternatives is noted in the report.

      • Ventilation and monitoring equipment suppliers

        Compatibility with ventilators is a factor for acceptance, and the report stresses the need to integrate with existing equipment.

      News & filings

      In the press

      No news in our archive over the last 180 days.

      Annual reports (ESEF)

      Sources

      1. [1] Annual report, fiscal year ended 2025-12-31 (ESEF) · SEC / Sedana Medical AB (publ) · 31 Dec 2025

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