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olivLaw · European equity research

Sequana Medical SEQUA.BR

Belgium · Euronext Brussels · ISIN BE0974340722 · Vertical: Listed companies from Belgium

0.61EUR0.00% · 1 dayClose 04 Nov 2026

Sequana Medical is a Belgian medical technology company developing the alfapump, an implantable device for refractory ascites from liver cirrhosis, and the DSR therapy for heart failure. In 2023 it was preparing a US launch after filing a PMA with the FDA, following a pivotal study in which 40 patients met the primary success criteria. For the company, the alfapump is the decisive test of whether the device can be commercialised and reimbursed in the US market.

At the close of 04 Nov 2026, Sequana Medical (SEQUA.BR) stock was 0.61 EUR (+0.00% on the day), with market capitalisation 16.3 m EUR, beta 1.00, 52-week range 0.47–0.76 EUR.

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

Market cap
16.3 m EUR
shares as of 31 Dec 2023
P/E (TTM)
unavailable
Diluted EPS TTM -1.22 · TTM to 31 Dec 2023
E/P (TTM)
-199.67%
TTM to 31 Dec 2023
Dividend yield
unavailable
Beta (2y)
1.00
Volatility (1y) 73%
52-week range
0.470.76

Price history

Loading chart…

Technical reading

RSI (14)
68.9
strong (55–70)
Bollinger (20, 2)
0.49 – 0.67
in the upper half of the band · %B 0.67 · band width 32.4%
SMA 50 / 200
0.54 / 0.72
mixed trend
MACD (12, 26, 9)
0.02 / 0.02
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 monthunavailable−0.6%unavailable—
3 monthsunavailable−4.2%unavailable—
6 monthsunavailable+4.3%unavailable—
Year to date−3.6%+7.5%−11.1 pp—
1 year−9.3%+9.9%−19.3 pp+6.3%
3 years−74.0%+49.8%−123.8 pp−6.5%
5 years−92.2%+42.8%−135.1 pp—
Max drawdown (1y)
−38.6%
28 Nov 2025 → 30 Mar 2026
Max drawdown (5y)
−94.2%
15 Dec 2021 → 30 Mar 2026
Compound annual growth (5y)
−40.0%
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 year202120222023
Revenue370.5 k922.7 k712.2 k
Revenue YoYunavailable+149.0%−22.8%
Net income-23.6 m-30.8 m-32.6 m
Net income YoYunavailableunavailableunavailable
Diluted EPS-1.30-1.35-1.22
Diluted EPS YoYunavailableunavailableunavailable
net %-6,373.8%-3,334.1%-4,572.4%
Free cash flow-23.9 m-28.2 m-29.8 m

Balance sheet & financial health

Fiscal year 2023 · 31 Dec 2023

Cash
2.6 m EUR
Financial debt
9.0 m EUR
Net debt
6.4 m EUR
Equity
-19.5 m EUR
Total assets
10.1 m EUR
Debt / equity
unavailable
Current ratio
0.32x
ROE
unavailable
ROA
-180.3%
FCF margin
-4,180.7%

Financial statements (source on every figure)

Revenue and net income (EUR)

Margins

Income statement · EUR

Revenue
2021
370.5 k
2022
922.7 k
2023
712.2 k

esef· 01 May 2024verified

Cost of revenue
2021
76.7 k
2022
204.6 k
2023
164.1 k

esef· 01 May 2024verified

Gross profit
2021
293.8 k
2022
718.1 k
2023
548.0 k

esef· 01 May 2024verified

Operating income
2021
-22.6 m
2022
-28.1 m
2023
-28.9 m

esef· 01 May 2024verified

Interest expense
2021
854.5 k
2022
2.7 m
2023
4.3 m

esef· 01 May 2024verified

Income tax
2021
393.3 k
2022
386.6 k
2023
465.6 k

esef· 01 May 2024verified

Net income
2021
-23.6 m
2022
-30.8 m
2023
-32.6 m

esef· 01 May 2024verified

Diluted EPS
2021
-1.30
2022
-1.35
2023
-1.22

esef· 01 May 2024verified

Balance sheet · EUR

Cash
2021
9.6 m
2022
18.9 m
2023
2.6 m

esef· 01 May 2024verified

Inventories
2021
2.1 m
2022
2.6 m
2023
2.3 m

esef· 01 May 2024verified

Current assets
2021
12.9 m
2022
23.1 m
2023
6.3 m

esef· 01 May 2024verified

Property, plant & equipment, net
2021
1.3 m
2022
2.1 m
2023
2.3 m

esef· 01 May 2024verified

Total assets
2021
14.7 m
2022
26.0 m
2023
10.1 m

esef· 01 May 2024verified

Long-term debt
2021
7.3 m
2022
12.2 m
2023
9.0 m

esef· 01 May 2024verified

Current liabilities
2021
7.2 m
2022
15.1 m
2023
19.5 m

esef· 01 May 2024verified

Equity
2021
-786.9 k
2022
-2.2 m
2023
-19.5 m

esef· 01 May 2024verified

Shares outstanding at year end
2021
18.2 m
2022
22.8 m
2023
26.7 m

esef· 01 May 2024derived

Cash flow · EUR

Operating cash flow
2021
-23.6 m
2022
-27.5 m
2023
-29.1 m

esef· 01 May 2024verified

Capex
2021
325.8 k
2022
676.7 k
2023
710.8 k

esef· 01 May 2024verified

Free cash flow
2021
-23.9 m ≈
2022
-28.2 m ≈
2023
-29.8 m ≈

esef· 01 May 2024derived

Investing cash flow
2021
-338.2 k
2022
-653.1 k
2023
-721.4 k

esef· 01 May 2024verified

Financing cash flow
2021
22.4 m
2022
37.3 m
2023
13.5 m

esef· 01 May 2024verified

Computed indicators

Growth

Revenue growth (YoY)
-22.8%
computed by olivLawFY 2023
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
77.0%
computed by olivLawFY 2023
EBITDA margin
unavailable
input data missing
EBIT margin
-4,052.7%
computed by olivLawFY 2023
Net margin
-4,572.4%
computed by olivLawFY 2023
FCF margin
-4,180.7%
computed by olivLawFY 2023

Returns

ROE
unavailable
equity is negative: the ratio is not economically meaningful (not by itself insolvency; usually the result of buybacks)
ROA
-180.3%
computed by olivLawFY 2023 · balance sheet at 31 Dec 2023
ROIC
unavailable
equity is negative: buybacks shrink the invested capital and ROIC would come out large without meaning anything
ROCE
unavailable
insufficient data
Payout ratio (EPS)
unavailable
input data missing
Payout ratio (FCF)
unavailable
input data missing

Balance sheet

Net debt
6.4 m EUR
computed by olivLawbalance sheet at 31 Dec 2023
Net debt / EBITDA
unavailable
input data missing
Debt / equity
unavailable
equity is negative: the ratio is not economically meaningful (not by itself insolvency; usually the result of buybacks)
Interest coverage
-6.7x
computed by olivLawFY 2023

Liquidity

Current ratio
0.3x
computed by olivLawbalance sheet at 31 Dec 2023
Quick ratio
0.2x
computed by olivLawbalance sheet at 31 Dec 2023
Cash ratio
0.1x
computed by olivLawbalance sheet at 31 Dec 2023

Cash

Operating cash flow
-29.1 m EUR
computed by olivLawFY 2023
Capital expenditure
710.8 k EUR
computed by olivLawFY 2023
Free cash flow
-29.8 m EUR
computed by olivLawFY 2023
FCF conversion
unavailable
insufficient data
Cash conversion
unavailable
input data missing

Efficiency

Days sales outstanding
unavailable
input data missing
Days inventory outstanding
5,467 days
computed by olivLawFY 2023 · balance sheet at 31 Dec 2023
Days payables outstanding
unavailable
input data missing
Cash conversion cycle
unavailable
input data missing

Market and valuation

Market capitalisation
16.3 m EUR
computed by olivLawbalance sheet at 31 Dec 2023
Enterprise value
22.7 m EUR
computed by olivLawbalance sheet at 31 Dec 2023
Market cap / net income TTM
unavailable
insufficient data
P/E (TTM)
unavailable
insufficient data
Earnings yield
-199.7%
computed by olivLawFY 2023
P/B
unavailable
equity is negative: the ratio is not economically meaningful (not by itself insolvency; usually the result of buybacks)
P/S
22.9x
computed by olivLawFY 2023 · balance sheet at 31 Dec 2023
EV/EBITDA
unavailable
input data missing
EV/EBIT
unavailable
insufficient data
EV/Sales
31.9x
computed by olivLawFY 2023 · balance sheet at 31 Dec 2023
P/FCF
unavailable
the base of the ratio is not positive
FCF yield
-182.6%
computed by olivLawFY 2023 · balance sheet at 31 Dec 2023
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

0.61 EUR

04 Nov 2026Source: olivLaw, closing series

Market cap: 16.3 m EUR

Key indicators

Market capitalisation
16.3 m EUR
computed by olivLawbalance sheet at 31 Dec 2023
P/E (TTM)
unavailable
insufficient data
P/B
unavailable
equity is negative: the ratio is not economically meaningful (not by itself insolvency; usually the result of buybacks)
EV/EBITDA
unavailable
input data missing
ROE
unavailable
equity is negative: the ratio is not economically meaningful (not by itself insolvency; usually the result of buybacks)
Net margin
-4,572.4%
computed by olivLawFY 2023
Revenue growth (YoY)
-22.8%
computed by olivLawFY 2023
Dividend yield
unavailable
no dividend in the structured statements; a missing line is not a confirmed zero

Coverage and freshness

22/37 reporting lines present
Latest full fiscal year: 2023
Latest reported period: 31 Dec 2023
Latest balance sheet date: 31 Dec 2023
Share count (cover of the latest filing), as of: 31 Dec 2023
Source: esefpublished 01 May 2024
verified 70derived 3

The data is older than the freshness threshold.

Score by group

25% · 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 · input data missing
  • 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

Assumptions (illustrative, editorial)

Risk-free rate
3.0%
Equity risk premium
5.5%
Beta (default)
1.00
Cost of equity
8.5%
Terminal growth
2.0%

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-4,572.4%0 (vs peers)25%
FCF conversion · Qualityunavailableunavailable—
Revenue CAGR 3Y · Growthunavailableunavailable—
EPS CAGR 3Y · Growthunavailableunavailable—
Net debt / EBITDA · Balance sheetunavailableunavailable—
Interest coverage · Balance sheet-6.7x0 (on a fixed band)25%
Current ratio · Balance sheet0.3x0 (on a fixed band)17%
P/E (TTM) · Valuationunavailableunavailable—
EV/EBITDA · Valuationunavailableunavailable—
FCF yield · Valuation-182.6%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 sheet0/100 · 2/3 factors with a value
  • Growth· partialunavailable · 0/2 factors with a value
  • Quality· partial0/100 · 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

Sequana Medical (SEQUA.BR). Latest full fiscal year: 2023; data up to 2023-12-31.

Figures computed from the financial statements: revenue 712.2 k EUR in 2023; YoY growth -22.8%; net margin -4,572.4%.

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

No signal among the computed factors. That is not an absence of risk: factors without data were not assessed, and business risks (margins, inventory, demand) are in the source-based analysis.

What contradicts it

  • Net margin: -4,572.4%
  • Interest coverage: -6.7x
  • Current ratio: 0.3x
  • FCF yield: -182.6%

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 Belgium · same country · compared with 39 companies

Multiples and returns vs the median

P/E
—
vertical median 17.2x
EV/EBITDA
—
vertical median 8.7x
P/S
22.9x
vertical median 1.0x
above median (+2,126.6%)
P/B
—
vertical median 1.1x
ROE
—
vertical median 8.3%
Net margin
-4,572.4%
vertical median 3.8%
below median (−121,354.2%)
EBIT margin
-4,052.7%
vertical median 7.9%
below median (−51,373.0%)
Revenue YoY
-22.8%
vertical median 1.0%
below median (−2,406.8%)
Net debt/EBITDA
—
vertical median 0.5x
Dividend yield
—
vertical median 2.1%

Price rebased to 100 (monthly, 5 years)

Companies in the vertical

Market capP/EROENet marginRevenue YoY1A / 3A
ELI.BRElia Group11.9 bn23.39.6%13.6%−2.0%+28% / +34%
LOTB.BRLotus Bakeries11.4 bn66.420.9%12.7%+10.0%+82% / +76%
GBLB.BRGroupe Bruxelles Lambert - Groep Brussel Lambert10.6 bn82.40.8%2.1%+1.0%+6% / +9%
DIE.BRD'ieteren Group9.7 bn23.2—5.3%−1.5%+22% / +16%
ACKB.BRAckermans & Van Haaren8.8 bn22.28.4%7.6%+18.6%+22% / +77%
COLR.BRColruyt Group4.4 bn14.69.4%2.9%+3.1%+12% / −6%
DEME.BRDeme Group4.2 bn12.215.5%8.3%+1.3%+21% / +72%
AZE.BRAzelis Group2.9 bn16.16.6%4.3%+1.5%+29% / −42%
MELE.BRMelexis2.1 bn12.430.7%18.4%−3.3%−1% / −38%
BEKB.BRNV Bekaert SA2.1 bn30.73.1%1.8%−6.4%+10% / −5%
FAGR.BRFagron1.8 bn22.216.7%9.2%+14.3%+15% / +40%
KIN.BRKinepolis Group1.4 bn33.919.3%7.0%−4.5%+62% / +11%
JEN.BRJensen Group706.9 m17.215.1%9.1%+13.3%+28% / +111%
BAR.BRBarco563.5 m9.17.9%6.7%−9.9%−48% / −59%
IBAB.BRIon Beam Applications487.2 m39.510.7%2.1%+24.5%+48% / +52%
DECB.BRDeceuninck341.3 m24.64.3%1.7%−4.5%+8% / +8%
CAMB.BRCampine272.3 m12.228.6%6.1%+13.4%−12% / +161%
CFEB.BRAannemingsmaatschappij Cfe266.8 m11.19.9%2.0%−5.3%+22% / +48%
EVS.BREvs Broadcast Equipment245.9 m6.020.8%21.7%+14.3%−49% / −36%
BPOST.BRBpost229.8 m3.56.3%1.5%−2.6%−39% / −75%
ECONB.BREconocom Group210.7 m40.51.2%0.2%+4.3%−1% / −36%
IMMO.BRImmobel172.2 m—-7.4%-25.2%−32.8%−24% / −36%
MONNI.BRKeyware Technologies171.0 m162.03.5%4.5%−5.9%−5% / −17%
HYSG.BRHybrid Software Group PLC121.3 m—-2.5%-5.5%+7.2%−4% / +13%
HYL.BRHyloris Pharmaceuticals96.4 m—-21.6%-87.9%−14.8%−42% / −69%

1- and 3-year price returns: for SEQUA.BR 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 (EUR)

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

    Sequana Medical is a Belgian medical technology company developing the alfapump, an implantable device for refractory ascites from liver cirrhosis, and the DSR therapy for heart failure. In 2023 it was preparing a US launch after filing a PMA with the FDA, following a pivotal study in which 40 patients met the primary success criteria. For the company, the alfapump is the decisive test of whether the device can be commercialised and reimbursed in the US market.

    SWOT

    Strengths

    • Positive pivotal data for the alfapump and breakthrough device designation from the FDA.
    • Clinical experience in Europe and the United States, with relationships built with opinion leaders.
    • A two-pillar portfolio, alfapump and DSR, which reduces dependence on a single product.

    Weaknesses

    • A history of operating losses and negative cash flow, without sufficient working capital for at least 12 months.
    • Reliance on external suppliers, some of them sole-source, and on third parties for clinical and regulatory work.
    • A small US commercial team and dependence on clinician adoption to build sales.

    Opportunities

    • A US launch could open a large market if FDA approval and reimbursement are confirmed.
    • A strategic partnership for DSR could accelerate development and commercialisation of the heart failure therapy.
    • CMS reimbursement mechanisms such as NTAP and TCET could support patient access to the alfapump.

    Threats

    • The PMA process can be lengthy, costly and uncertain, and requirements may change.
    • Payment pressure and possibly insufficient reimbursement could reduce the company's margin.
    • Competition from large device and pharmaceutical companies could grow over time.

    Risks

    • Funding and working capitalhigh

      The company lacks sufficient capital for at least 12 months and will need additional funds for investment, which could dilute shareholders.

    • Regulatory approvalhigh

      PMA approval could be delayed or not obtained, and regulations could change the conditions of commercialisation.

    • Reimbursement and pricinghigh

      Commercial success depends on third-party payment; if reimbursement levels are insufficient, sales could be limited.

    • Supplier dependencemedium

      Some components and services come from a single supplier, and interruptions could affect production.

    • Clinical outcomes and adverse eventsmedium

      Adverse events could delay studies or prevent their completion, and an implantable therapy carries surgical risks.

    Investment thesis

    What would need to be true (bull case)

    • If the alfapump obtains FDA approval and is reimbursed through CMS mechanisms, the company could open a significant commercial market in the US.
    • Positive pivotal data and longer-term results could support adoption by transplant centres.
    • If DSR finds a strategic partner, development could advance faster without exhausting the company's resources.

    What would break the thesis

    • The company has historical losses and may need additional funding, which could dilute shareholders.
    • If FDA approval is delayed or reimbursement is insufficient, the commercial launch could become more costly than planned.
    • DSR is still at an early stage, and if the MOJAVE study does not confirm earlier results, the value of this direction could be limited.

    What to watch

    • FDA decision on the alfapump PMA application2025
    • US commercial launch and first alfapump sales2025
    • MOJAVE study results and progress of the DSR partnership frameworknext 10-K
    • Confirmation of NTAP and TCET coverage for the alfapump2025

    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

    Sequana Medical operates in medical devices and therapies for cardiorenal and liver conditions. Its lead product, the alfapump, is an implantable pump that drains fluid from the abdomen of patients with recurrent or refractory ascites caused by cirrhosis. In the Pivotal Cohort 40 patients received the implant, and another 29 were included in the Roll-In Cohort 1. The company filed a PMA with the FDA in December 2023 and targets a commercial launch in 2025 1.

    The second pillar is DSR (Direct Sodium Removal) therapy for heart failure, designed to remove excess sodium from the body and reduce reliance on loop diuretics. The company reported results from the RED DESERT and SAHARA studies and is running the MOJAVE study to confirm them 1. DSR development is earlier stage and depends on a strategic partnership the company is considering 1.

    The revenue model rests on selling the device to hospitals, with reimbursement through CPT codes and DRG payments, and the company targets a price of about 30000 USD per pump 1. The initial commercial focus is on adult liver transplant centres, with a limited US sales team 1.

    Segments

    Alfapump (liver ascites)

    The alfapump is the product with the most advanced development. The pivotal POSEIDON study showed a median 100% reduction in therapeutic paracentesis at six months and an estimated 70% survival at 12 and 18 months after implantation 1. The PMA is under FDA review, and commercial success depends on clinician adoption and reimbursement 1.

    DSR (heart failure)

    DSR targets cardiorenal syndrome, a clinical problem with few effective options. Preliminary data from RED DESERT and SAHARA show improved diuretic response and reduced need for loop diuretics, but the MOJAVE study is still early 1. The company has no confirmed commercial path and intends to seek a strategic partner 1.

    Market context

    The US market targeted by the alfapump is concentrated in about 125 adult liver transplant centres, of which 90 cover 95% of implantations 1. The company says NASH-related cirrhosis is becoming an important driver of the North American market, and a patient preference study indicated a 65% likelihood that patients would choose the alfapump over large-volume paracentesis 1.

    The DSR heart failure market is broader but competitive and dependent on established therapies. The company points to the lack of treatments that improve outcomes in cardiorenal syndrome and argues that DSR could fill an unmet niche 1.

    Trends

    • FDA approval processmixed

      Breakthrough device status and acceptance of the PMA for substantive review could speed up the evaluation of the alfapump. If approval arrives on the expected timeline, the commercial launch could begin in 2025 1.

    • CMS coverage and CPT codestailwind

      New category III CPT codes available from July 2024 and a possible NTAP payment could support reimbursement for the alfapump. If these mechanisms work, patient access could grow 1.

    • Pricing and margin pressureheadwind

      The targeted price and gross margin depend on DRG and NTAP payments, and any cut in reimbursement could affect the alfapump margin 1.

    • Geopolitical tensions and supply chainsheadwind

      Conflicts in Eastern Europe and the Middle East could disrupt the company's supply chain or macroeconomic conditions 1.

    Competitive position

    The analysed source does not give a full list of competitors. Competition comes from other medical device companies, pharmaceutical firms and their device subsidiaries, which the filing describes as significant and growing 1. For refractory ascites, the main alternative remains large-volume paracentesis, the standard procedure the alfapump aims to replace 1.

    • Large-volume paracentesis (standard of care)

      The reference procedure the alfapump aims to replace, according to the patient preference study in the filing.

    • Large medical device companies

      Competition the filing describes as significant and growing, without named companies in the analysed source.

    • Pharmaceutical companies and device subsidiaries

      Players that could develop alternative heart failure and cardiorenal therapies, mentioned generically in the filing.

    • Loop diuretics (standard heart failure therapy)

      The standard treatment DSR seeks to reduce, given their negative effects on cardiorenal syndrome.

    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 2023-12-31 (ESEF) · SEC / Sequana Medical · 31 Dec 2023

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