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olivLaw · US equity research

FocalTherics™ (formerly EDAP TMS S.A.) FOCL

Electromedical & Electrotherapeutic Apparatus · SIC 3845 · Vertical: Electromedical & Electrotherapeutic Apparatus (SIC 3845)

4.34USD+5.60% · 1 dayClose 04 Nov 2026

FocalTherics (formerly EDAP TMS, Nasdaq: FOCL) develops and sells robotic focal therapy devices based on high-intensity focused ultrasound (HIFU), with its flagship Focal One system. The company has refocused exclusively on HIFU, and HIFU division revenue rose 44.8% in fiscal 2025, making the transition relevant for investors and patients.

At the close of 04 Nov 2026, FocalTherics™ (formerly EDAP TMS S.A.) (FOCL) stock was 4.34 USD (+5.60% on the day), with beta 0.76, 52-week range 1.99–6.34 USD. Latest reported quarter (Q2 2026): revenue of 13.2 m USD (+38.8% YoY), net income of -14.5 m USD, diluted EPS -0.39 USD.

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

Market cap
unavailable
shares as of 14 Aug 2026
P/E (TTM)
unavailable
Diluted EPS TTM -0.78 · TTM to 31 Dec 2025
E/P (TTM)
unavailable
TTM to 31 Dec 2025
Dividend yield
unavailable
Beta (2y)
0.76
Volatility (1y) 68%
52-week range
1.996.34

Price history

Loading chart…

Technical reading

RSI (14)
53.0
neutral
Bollinger (20, 2)
4.00 – 4.38
in the upper half of the band · %B 0.90 · band width 9.1%
SMA 50 / 200
4.25 / 4.41
mixed trend
MACD (12, 26, 9)
-0.02 / -0.04
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

CompanyS&P 500vs S&P 500Vertical median
1 month+2.6%−1.1%+3.7 pp—
3 months−28.7%−0.5%−28.3 pp—
6 months+20.6%+4.4%+16.2 pp—
Year to date+31.9%+12.3%+19.6 pp—
1 year+113.8%+13.5%+100.3 pp−0.4%
3 years−38.9%+76.4%−115.3 pp−29.1%
5 years−23.9%+63.7%−87.5 pp—
Max drawdown (1y)
−37.1%
04 Aug 2026 → 14 Oct 2026
Max drawdown (5y)
−90.0%
03 Mar 2023 → 06 Aug 2025
Compound annual growth (5y)
−5.3%
S&P 500 +10.4%

Price returns, dividends excluded.

Quarterly results

Latest quarter: Q2 2026 · 30 Jun 2026

Revenue
13.2 m EUR
+38.8% YoY
Net income
-14.5 m EUR
unavailable YoY
Diluted EPS
-0.39
unavailable YoY
net / operating
-109.7% / -60.8%

Quarterly margins

Quarterly statements · EUR

Fiscal yearQ1 '25Q2 '25Q1 '26Q2 '26
Revenue14.3 m9.5 m17.8 m13.2 m
Cost of revenue8.3 m4.6 m9.7 m5.9 m
Gross profit6.0 m4.9 m8.1 m7.3 m
Research & development2.6 m2.3 m2.6 m2.3 m
Operating income-6.3 m-6.6 m-7.4 m-8.0 m
Depreciation & amortisation753.0 k846.0 k ≈896.0 k1.0 m ≈
Pre-tax income-7.3 m-6.3 m-8.9 m-14.4 m
Income tax144.0 k14.0 k145.0 k8.0 k
Net income-7.4 m-6.4 m-9.1 m-14.5 m
Diluted EPS-0.20-0.17-0.24-0.39
Operating cash flow-5.3 m-4.7 m ≈-3.0 m-3.7 m ≈

≈ derived quarter (cumulative difference / share-days average)

E/P over time

the price (USD) and the reports are in different currencies

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 year20182019202020212022202320242025
Revenue39.2 m44.9 m41.6 m44.1 m55.1 munavailable69.4 m70.5 m
Revenue YoY+9.7%+14.5%−7.2%+5.8%+25.1%unavailableunavailable+1.6%
Net incomeunavailableunavailableunavailableunavailableunavailableunavailable-20.6 m-29.2 m
Net income YoYunavailableunavailableunavailableunavailableunavailableunavailableunavailableunavailable
Diluted EPSunavailableunavailableunavailableunavailableunavailableunavailable-0.55-0.78
Diluted EPS YoYunavailableunavailableunavailableunavailableunavailableunavailableunavailableunavailable
net %unavailableunavailableunavailableunavailableunavailableunavailable-29.7%-41.5%
Free cash flowunavailableunavailableunavailableunavailableunavailableunavailableunavailableunavailable

Reported results vs expectations

Loading…

Balance sheet & financial health

Fiscal year 2025 · 31 Dec 2025

Cash
20.5 m EUR
Financial debt
20.3 m EUR
Net debt
-163.0 k EUR
Equity
19.4 m EUR
Total assets
79.0 m EUR
Debt / equity
1.05x
Current ratio
1.54x
ROE
-94.5%
ROA
-34.7%
FCF margin
unavailable

Financial statements (source on every figure)

Revenue and net income (EUR)

Margins

Income statement · EUR

Revenue
2023
—
2024
69.4 m
2025
70.5 m

SEC (XBRL)· 25 Mar 2026verified

Cost of revenue
2023
—
2024
40.7 m
2025
40.5 m

SEC (XBRL)· 25 Mar 2026verified

Gross profit
2023
—
2024
28.7 m
2025
30.0 m

SEC (XBRL)· 25 Mar 2026verified

Research & development
2023
—
2024
8.4 m
2025
9.7 m

SEC (XBRL)· 25 Mar 2026verified

Operating income
2023
—
2024
-22.2 m
2025
-24.7 m

SEC (XBRL)· 25 Mar 2026verified

Depreciation & amortisation
2023
—
2024
2.8 m
2025
3.4 m

SEC (XBRL)· 25 Mar 2026verified

EBITDA
2023
—
2024
-19.4 m ≈
2025
-21.3 m ≈

SEC (XBRL)· 25 Mar 2026derived

Interest expense
2023
232.0 k
2024
256.0 k
2025
789.0 k

SEC (XBRL)· 25 Mar 2026verified

Pre-tax income
2023
—
2024
-20.3 m
2025
-28.8 m

SEC (XBRL)· 25 Mar 2026verified

Income tax
2023
—
2024
313.0 k
2025
438.0 k

SEC (XBRL)· 25 Mar 2026verified

Net income
2023
—
2024
-20.6 m
2025
-29.2 m

SEC (XBRL)· 25 Mar 2026verified

Diluted EPS
2023
—
2024
-0.55
2025
-0.78

SEC (XBRL)· 25 Mar 2026verified

Weighted average diluted shares
2023
37.0 m
2024
37.3 m
2025
37.4 m

SEC (XBRL)· 25 Mar 2026verified

Balance sheet · EUR

Cash
2023
48.0 m
2024
31.0 m
2025
20.5 m

SEC (XBRL)· 25 Mar 2026verified

Receivables
2023
—
2024
19.3 m
2025
14.9 m

SEC (XBRL)· 14 Aug 2026verified

Inventories
2023
—
2024
19.2 m
2025
7.8 m

SEC (XBRL)· 14 Aug 2026verified

Current assets
2023
—
2024
72.6 m
2025
57.2 m

SEC (XBRL)· 25 Mar 2026verified

Property, plant & equipment, net
2023
—
2024
7.6 m
2025
9.9 m

SEC (XBRL)· 25 Mar 2026verified

Goodwill
2023
—
2024
2.5 m
2025
757.0 k

SEC (XBRL)· 14 Aug 2026verified

Intangibles (excl. goodwill)
2023
—
2024
1.1 m
2025
1.8 m

SEC (XBRL)· 14 Aug 2026verified

Total assets
2023
—
2024
89.4 m
2025
79.0 m

SEC (XBRL)· 25 Mar 2026verified

Short-term debt
2023
—
2024
6.5 m
2025
4.4 m

SEC (XBRL)· 14 Aug 2026verified

Long-term debt
2023
—
2024
2.2 m
2025
15.9 m

SEC (XBRL)· 25 Mar 2026verified

Current liabilities
2023
—
2024
39.3 m
2025
37.1 m

SEC (XBRL)· 25 Mar 2026verified

Total liabilities
2023
—
2024
46.9 m
2025
59.6 m

SEC (XBRL)· 25 Mar 2026verified

Equity
2023
62.9 m †
2024
42.5 m †
2025
19.4 m †

SEC (XBRL)· 25 Mar 2026verified

Shares outstanding at year end
2023
37.1 m
2024
37.4 m
2025
—

SEC (XBRL)· 27 Mar 2025verified

Cash flow · EUR

Operating cash flow
2023
—
2024
-14.7 m
2025
-16.4 m

SEC (XBRL)· 25 Mar 2026verified

Investing cash flow
2023
—
2024
-4.5 m
2025
-5.7 m

SEC (XBRL)· 25 Mar 2026verified

Financing cash flow
2023
—
2024
5.0 m
2025
8.6 m

SEC (XBRL)· 25 Mar 2026verified

Computed indicators

Growth

Revenue growth (YoY)
1.6%
computed by olivLawFY 2025
Revenue CAGR 3Y
8.6%
computed by olivLawFY 2022 → FY 2025
Revenue CAGR 5Y
11.1%
computed by olivLawFY 2020 → FY 2025
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
input data missing

Profitability

Gross margin
44.5%
computed by olivLawTTM to 30 Jun 2026
EBITDA margin
-29.8%
computed by olivLawTTM to 30 Jun 2026
EBIT margin
-34.5%
computed by olivLawTTM to 30 Jun 2026
Net margin
-49.1%
computed by olivLawTTM to 30 Jun 2026
FCF margin
unavailable
input data missing

Returns

ROE
-321.7%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
ROA
-52.3%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
ROIC
unavailable
equity is negative: buybacks shrink the invested capital and ROIC would come out large without meaning anything
ROCE
-72.6%
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
17.5 m EUR
computed by olivLawbalance sheet at 30 Jun 2026
Net debt / EBITDA
unavailable
insufficient data
Debt / equity
unavailable
equity is negative: the ratio is not economically meaningful (not by itself insolvency; usually the result of buybacks)
Interest coverage
-34.7x
computed by olivLawTTM to 30 Jun 2026

Liquidity

Current ratio
1.6x
computed by olivLawbalance sheet at 30 Jun 2026
Quick ratio
1.4x
computed by olivLawbalance sheet at 30 Jun 2026
Cash ratio
0.6x
computed by olivLawbalance sheet at 30 Jun 2026

Cash

Operating cash flow
-13.0 m EUR
computed by olivLawTTM to 30 Jun 2026
Capital expenditure
unavailable
input data missing
Free cash flow
unavailable
input data missing
FCF conversion
unavailable
input data missing
Cash conversion
unavailable
insufficient data

Efficiency

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

Market and valuation

Market capitalisation
unavailable
input data missing
Enterprise value
unavailable
input data missing
Market cap / net income TTM
unavailable
input data missing
P/E (TTM)
unavailable
input data missing
Earnings yield
unavailable
input data missing
P/B
unavailable
input data missing
P/S
unavailable
input data missing
EV/EBITDA
unavailable
input data missing
EV/EBIT
unavailable
input data missing
EV/Sales
unavailable
input data missing
P/FCF
unavailable
input data missing
FCF yield
unavailable
input data missing
Dividend yield
unavailable
input data missing
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

4.34 USD

04 Nov 2026Source: olivLaw, closing series

Market cap: unavailable

Price and reporting are in different currencies; market indicators are unavailable.

Key indicators

Market capitalisation
unavailable
input data missing
P/E (TTM)
unavailable
input data missing
P/B
unavailable
input data missing
EV/EBITDA
unavailable
input data missing
ROE
-321.7%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
Net margin
-49.1%
computed by olivLawTTM to 30 Jun 2026
Revenue growth (YoY)
1.6%
computed by olivLawFY 2025
Dividend yield
unavailable
input data missing

Coverage and freshness

30/37 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: 14 Aug 2026
Source: SEC (XBRL)published 14 Aug 2026
verified 310

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 input exists, but its latest figure is far older than the latest reported period: not used
  • Peers: EV/EBITDAunavailable · the base of the ratio is not positive
  • Peers: P/Eunavailable · the base of the ratio is not positive
  • Dividend discount (DDM)unavailable · the company pays no dividend: a dividend model needs an explicit initiation assumption

no valuation method could be computed

Multiple comparisons use the SIC vertical: Electromedical & Electrotherapeutic Apparatus (SIC 3845)

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
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-49.1%45 (vs peers)25%
FCF conversion · Qualityunavailableunavailable—
Revenue CAGR 3Y · Growth8.6%71 (on a fixed band)33%
EPS CAGR 3Y · Growthunavailableunavailable—
Net debt / EBITDA · Balance sheetunavailableunavailable—
Interest coverage · Balance sheet-34.7x0 (on a fixed band)25%
Current ratio · Balance sheet1.6x67 (on a fixed band)17%
P/E (TTM) · Valuationunavailableunavailable—
EV/EBITDA · Valuationunavailableunavailable—
FCF yield · Valuationunavailableunavailable—
Shareholder yield (distributions) · Returnsunavailableunavailable—
Payout ratio (FCF) · Returnsunavailableunavailable—

Factors without a value were dropped; the remaining weights were renormalised.

Score groups

  • Balance sheet27/100 · 2/3 factors with a value
  • Growth· partial71/100 · 1/2 factors with a value
  • Quality· partial45/100 · 1/3 factors with a value
  • Returns· partialunavailable · 0/2 factors with a value
  • Valuation· partialunavailable · 0/3 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

EDAP TMS SA (FOCL). Latest full fiscal year: 2025; data up to 2026-06-30.

Figures computed from the financial statements: revenue 70.5 m EUR in 2025; YoY growth 1.6%; net margin -49.1%; ROE -321.7%.

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

  • Revenue CAGR 3Y: 8.6%

What contradicts it

  • Interest coverage: -34.7x

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

Versus the vertical median

Electromedical & Electrotherapeutic Apparatus (SIC 3845) · same industry (4-digit SIC) · compared with 24 companies

Multiples and returns vs the median

P/E
—
vertical median 23.8x
EV/EBITDA
—
vertical median 18.2x
P/S
—
vertical median 3.2x
P/B
—
vertical median 4.3x
ROE
-321.7%
vertical median -52.5%
below median
Net margin
-49.1%
vertical median -22.7%
below median
EBIT margin
-34.5%
vertical median -18.0%
below median
Revenue YoY
1.6%
vertical median 16.7%
below median (−90.2%)
Net debt/EBITDA
—
vertical median -2.0x
Dividend yield
—
vertical median 0.6%

Price rebased to 100 (monthly, 5 years)

Companies in the vertical

Market capP/EROENet marginRevenue YoY1A / 3A
MDTMedtronic plc134.3 bn25.810.7%13.9%+8.4%−0% / +32%
LIVNLivaNova PLC5.2 bn31.315.5%13.0%+10.7%+48% / +110%
ITGRInteger Holdings Corporation4.3 bn42.56.0%5.7%+8.0%+75% / +45%
AXGNAxogen, Inc.3.1 bn—-10.3%-12.0%+20.2%+79% / +684%
TMDXTransMedics Group, Inc.2.5 bn18.936.3%22.7%+37.1%−50% / −4%
BLFSBioLife Solutions, Inc.1.9 bn33.515.1%56.4%+28.9%unavailable / unavailable
CNMDConmed Corporation1.6 bn21.87.1%5.4%+5.2%+24% / −50%
CBLLCeriBell, Inc.1.1 bn—-52.5%-68.0%+36.1%+61% / unavailable
INMDInMode Ltd.899.7 m9.913.5%25.3%−6.2%−0% / −40%
CVCapsoVision, Inc342.8 m——-214.7%+15.3%+23% / unavailable
ELMDElectromed, Inc.234.3 m21.523.3%15.3%+15.3%+5% / +172%
FOCLEdap Tms SA162.9 m—-321.7%-49.1%+1.6%+114% / −39%
VANIVivani Medical, Inc.96.5 m—-220.4%—unavailable−21% / +13%
STXSStereotaxis, Inc.95.9 m—-325.9%-74.2%+20.3%−61% / −42%
NRXSNeuraxis, Inc.86.1 m—-139.8%-144.4%+32.9%+147% / +117%
OMOutset Medical, Inc.83.8 m—-63.0%-58.3%+5.1%−3% / −94%
ECORelectroCore, Inc.77.5 m——-33.5%+27.2%+66% / +49%
POCIPrecision Optics Corporation, Inc.53.1 m—-22.3%-11.5%+65.2%+3% / −18%
NXLNexalin Technology, Inc.34.4 m—-240.3%-4,139.4%+78.8%−95% / −87%
QTIQt Imaging Holdings, Inc.32.1 m—-2,125.0%-77.3%+287.9%−64% / −99%
NUWENuwellis, Inc.19.2 m——-125.6%−5.4%−94% / −100%
IRIXIridex Corp12.6 m—-73.1%-6.9%unavailable−26% / −72%
NDRAEndra Life Sciences Inc.7.4 m—-152.0%—unavailable−16% / −100%
HYPRHyperfine, Inc.0—-97.0%-210.8%+5.2%−30% / −41%
ITOCiTonic Holdings Ltd——-82.8%-974.7%+16.7%−80% / unavailable

1- and 3-year price returns: for FOCL 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

Scenarios are not available. input data missing

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

FocalTherics (formerly EDAP TMS, Nasdaq: FOCL) develops and sells robotic focal therapy devices based on high-intensity focused ultrasound (HIFU), with its flagship Focal One system. The company has refocused exclusively on HIFU, and HIFU division revenue rose 44.8% in fiscal 2025 1, making the transition relevant for investors and patients.

SWOT

Strengths

  • Proprietary HIFU platform with published comparative clinical data and FDA and CE authorisations for several indications.
  • Rapid growth in equipment and treatment sales, with gross margin rising in the first half of 2026 2.
  • Clear strategic focus on one main product, which simplifies operations and research investment.

Weaknesses

  • Recurring net losses and rising sales and marketing costs, with a large net loss in 2025 1.
  • Significant debt and reliance on European Investment Bank financing, with profit effects from warrant valuation changes.
  • Dependence on a single manufacturing site and a small number of suppliers.

Opportunities

  • Expansion into BPH and endometriosis, with a programme already launched in Europe.
  • The U.S. market, where procedure growth was reported as strong in the second quarter of 2026 3.
  • Integration of histotripsy and telecollaboration into the Focal One platform, if development succeeds.

Threats

  • Tariff pressure and geopolitical instability affecting costs and international sales.
  • Risk that reimbursement or adoption by the medical community is slower than expected.
  • Risk that new technologies make the platform obsolete or less competitive.

Risks

  • Need for additional financinghigh

    The company could need additional capital, and terms of new financing could be unfavourable to existing shareholders 1.

  • Dependence on HIFU technologyhigh

    Strategic success depends almost entirely on HIFU technology; failure to expand indications could weigh on growth 1.

  • Exit from legacy segmentsmedium

    Exiting ESWL and Distribution could weigh on revenue until the transactions are completed 12.

  • Product liability and AI issuesmedium

    Misuse of products or problems with AI could lead to legal liability or reputational harm 1.

  • Volatile results and currency exposurelow

    Quarterly results have fluctuated significantly and currency exposure could affect margins 1.

Investment thesis

What would need to be true (bull case)

  • If growth in HIFU revenue and gross margin holds, the company could gradually reduce operating losses.
  • Comparative clinical data and authorisations for several indications could support broader adoption of the Focal One platform.
  • Exiting legacy activities could focus resources on the higher-margin segment.

What would break the thesis

  • Net losses and the need for additional financing could limit the company's ability to invest in growth.
  • Dependence on one product and one manufacturing site could leave the company exposed to disruption.
  • Slow physician adoption or limited reimbursement could delay reaching growth targets.

What to watch

  • Revenue guidance for 2026 and delivery in coming quartersQ3 2026
  • Completion of the 40 million USD public offering and use of proceedsQ3 2026
  • Progress of Focal One system sales and installed base in the U.S. and EuropeQ3 2026
  • Timing and terms of the exits from ESWL and Distribution2027

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

Founded in 1979 as a French société anonyme and headquartered in Vaulx-en-Velin, the company focuses on HIFU technology, whose main commercial product is Focal One Robotic HIFU, used to ablate prostate tumour tissue in focal treatment 1. The business model combines equipment sales with recurring revenue from consumables, treatments (RPP and leases) and maintenance services for the installed base 1. In May 2026 management decided to exit the ESWL and Distribution segments, and the company announced a rename to FocalTherics with a focus solely on robotic focal therapy 23.

Expansion of clinical indications is central to the strategy: the company sponsors studies for benign prostatic hyperplasia (BPH) and holds a Breakthrough Device designation for deep infiltrating endometriosis, with a CE mark for rectal endometriosis from March 2025 1. A commercial endometriosis programme was launched in Europe in the second quarter of 2026 3.

Research and development rests on three pillars: imaging and targeting precision, automation and software intelligence (including AI algorithms in development), and expansion into new urologic and non-urologic indications 1. In November 2025 the system received FDA 510(k) clearance for the latest Focal One i evolution 1.

Segments

HIFU (Focal One)

The HIFU segment is the only continuing segment. Its revenue grew 44.8% in fiscal 2025 to 37.4 million USD 1, and total revenue in the first half of 2026 reached 24.8 million USD 2. Guidance for 2026 targets between 50.0 and 54.0 million USD 3.

ESWL and Distribution

The ESWL (lithotripsy) and Distribution segments are being exited and are reported as discontinued operations from the second quarter of 2026 23. Until the transactions, which could be completed within one year of the held-for-sale classification, their results are excluded from continuing revenue 2.

Market context

The addressable market is treatment of localized prostate cancer and, potentially, endometriosis and benign prostatic hyperplasia. The company reports an installed base of 184 Focal One systems at June 30, 2026, of which 96 are in the United States 3. The U.S. share of net sales rose to 40% in 2025 from 28% in 2024 1.

Demand for focal therapy could grow if clinical studies such as FARP and HIFI confirm non-inferiority to surgery over the long term 1. Commercial success, however, depends on reimbursement by health authorities and third-party payers, which is not assured 1.

Trends

  • Adoption of focal therapy as an alternative to surgerytailwind

    The FARP and HIFI studies suggest focal therapy could become a standard option for some patients with localized prostate cancer 1. If adoption grows, demand for Focal One could develop favourably.

  • Expansion of clinical indicationstailwind

    Programmes for BPH and endometriosis could widen the addressable market of the Focal One platform, if clinical results and regulatory approvals are confirmed 13.

  • Tariff and trade policy pressureheadwind

    Changes in U.S. trade policy, including tariffs, could affect the company's costs and margins, according to its declared risk factors 1.

  • Reliance on financing and cyclical demandmixed

    The company notes that its cash flow depends on cyclical product demand and that additional financing may be needed, which could constrain growth plans 1. The announced public offering is a step in that direction 3.

Competitive position

The reviewed sources do not name competitors, so competitive positioning is described only through the company's own technology and reported clinical advantages 1. The company states that HIFU could offer an advantage over surgery and radiotherapy, based on comparative study data 1.

Competitive risk is described as substantial: the company's products or services could become obsolete or uncompetitive 1. A rival technology could narrow the Focal One advantage in certain indications.

  • Surgical treatment (robotic radical prostatectomy)

    The standard alternative for prostate cancer; the FARP and HIFI studies compare focal results with prostatectomy 1.

  • External beam radiotherapy (EBRT)

    Compared with HIFU in a 10-year retrospective study cited by the company 1.

  • Other makers of therapeutic ultrasound systems

    The sources do not name rivals; the risk of new industry devices is mentioned in the risk factors 1.

  • Developers of imaging and AI technology in urology

    The company cites AI algorithm development as an advantage but also as a reputational risk 1.

News & filings

In the press

No news in our archive over the last 180 days.

SEC filings

Sources

  1. [1] Form 10-K, fiscal year ended 2025-12-31 · SEC / FocalTherics™ (formerly EDAP TMS S.A.) · 25 Mar 2026
  2. [2] Form 10-Q, quarter ended 2026-06-30 · SEC / FocalTherics™ (formerly EDAP TMS S.A.) · 14 Aug 2026
  3. [3] Form 8-K, results release (exhibit 99.1) · SEC / FocalTherics™ (formerly EDAP TMS S.A.) · 13 Aug 2026

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