EDAP TMS (EDAP) AI Stock Analysis

• Market Cap: $157.05M
• Dividend Yield: N/A
• Average Volume (3M): 61.70K
• Price to Earnings (P/E): ―
• Beta (1Y): 0.97
• Revenue Growth: N/A
• EPS Growth: N/A
• Country: US
• Employees: 310
• Sector: Healthcare
• Sector Strength: 45
• Industry: Medical - Devices
• EPS (TTM): -0.15
• Shares Outstanding: 37,392,086
• 10 Day Avg. Volume: 79,633
• 30 Day Avg. Volume: 61,700
• PEG Ratio: 0.40
• Price to Book (P/B): 1.95
• Price to Sales (P/S): 1.24
• P/FCF Ratio: -4.50
• Enterprise Value/Market Cap: 0.82
• Enterprise Value/Revenue: 2.03
• Enterprise Value/Gross Profit: 4.69
• Enterprise Value/Ebitda: -7.27
• 1Y Price Target: $8.25
• Price Target Upside: 96.43% Upside
• Rating Consensus: Moderate Buy
• Number of Analyst Covering: 2
• EPS Forecast (FY): N/A
• Revenue Forecast (FY): N/A

• Rating: 54 Neutral
• Price Target: $4.00 ▼(-4.76% Downside)

The score is held back primarily by weak financial performance (ongoing losses and negative operating/free cash flow), despite strong technical momentum and encouraging earnings-call fundamentals around accelerating HIFU growth and maintained guidance. Valuation is neutral-to-weak due to negative earnings and no dividend support.

Positive Factors

HIFU Revenue & Placements

Sustained double-digit HIFU revenue growth and a large uptick in system placements indicate durable product-market fit and recurring procedure revenue. Higher placements expand installed base, support service and consumable sales, and improve long-term revenue visibility and unit economics.

Regulatory Approval (FDA)

FDA 510(k) clearance for imaging and workflow enhancements materially lowers adoption barriers in the U.S., enabling wider clinical use and procurement by hospitals. Regulatory validation supports differentiation, drives reimbursement conversations, and underpins sustainable commercial expansion.

EIB Credit Facility for R&D

A €36M EIB facility provides multi-year, programmatic financing to advance robotic HIFU R&D, reducing dilution or near-term liquidity pressure. Structured tranches align funding to milestones, enabling sustained innovation and scale-up that support long-term competitiveness.

Negative Factors

Negative Cash Flows

Persistent negative operating and free cash flows indicate the core business currently consumes cash, limiting internal funding for growth and increasing dependence on external financing. Sustained cash burn reduces financial flexibility and raises execution risk over the medium term.

Ongoing Operating Losses

Continued operating losses and negative EBIT margins suggest the company has not yet achieved scalable cost structure. Until margins convert positive, profitability depends on sustained revenue mix shifts to higher-margin HIFU and disciplined SG&A, creating execution sensitivity.

Declining Cash Reserves

A rapid drop in cash balances materially shortens runway and increases reliance on credit or equity to fund operations and placements. Lower liquidity constrains ability to support inventory, service network expansion, and reimbursement initiatives critical to sustaining HIFU adoption.

EDAP TMS Business Overview & Revenue Model

Company Description

EDAP TMS S.A., together with its subsidiaries, develops, produces, markets, distributes, and maintains a portfolio of minimally invasive medical devices for the treatment of urological diseases in Asia, France, the United States, and internationally. It operates in three segments: High Intensity Focused Ultrasound (HIFU), Extracorporeal ShockWave Lithotripsy (ESWL), and Distribution Services (DIST). The HIFU segment develops, manufactures, and markets medical devices based on HIFU technology for the minimally invasive treatment of urological and other clinical indications. This segment also offers Ablatherm, an ultrasound guided robotic HIFU device for the treatment of organ-confined prostate cancer; Ablatherm Fusion that incorporates the company's proprietary fusion software, which merges MRI and ultrasound images; and the Focal One, a HIFU robotic device dedicated to the focal therapy of prostate cancer, as well as disposables, and leasing and treatment related services; and maintenance services. The ESWL division manufactures, markets, and services lithotripter for the treatment of urinary tract stones by means of ESWL technology; and offers Sonolith i-move, an extracorporeal shockwave lithotripter to small and mid-size hospitals, as well as sells disposable parts for lithotripters and electrodes. The Distribution division markets, distributes, and services lasers, micro-ultrasound systems, and other medical products from third parties, as well as leases devices; sells disposables and spare parts; and offers maintenance services. The company markets and sells its products through its direct marketing, sales organization, and service platform, as well as through third-party distributors and agents. Its customers include hospitals, urology clinics, and research institutions. The company was incorporated in 1979 and is headquartered in Lyon, France.

How the Company Makes Money

EDAP generates revenue through multiple streams, primarily by selling its medical devices and related services to hospitals, clinics, and healthcare providers. The company earns income from the direct sale of its Ablatherm® HIFU system and lithotripsy devices, as well as from the consumables and accessories associated with these systems. Additionally, EDAP offers training and support services for healthcare professionals, which also contribute to its revenue. Significant partnerships with healthcare institutions and collaborations with research organizations enhance its market reach and facilitate the adoption of its technologies, further driving sales and revenue growth.

EDAP TMS Financial Statement Overview

Summary

Revenue growth is a positive, but profitability remains weak with persistent negative net income/EBIT margins. The balance sheet is moderately stable with manageable leverage, yet negative ROE and declining equity are concerns. Cash flow is the biggest drag, with negative operating and free cash flow indicating ongoing operational strain.

Income Statement

EDAP TMS shows a mixed performance in its income statement. The company has experienced revenue growth, with a notable increase in the TTM period. However, profitability remains a concern, as indicated by negative net profit margins and EBIT margins. The gross profit margin is relatively stable, but the consistent negative net income suggests challenges in managing operational costs effectively.

Balance Sheet

The balance sheet reflects moderate financial stability. The debt-to-equity ratio is manageable, indicating a balanced approach to leveraging. However, the negative return on equity highlights inefficiencies in generating returns for shareholders. The equity ratio suggests a reasonable level of equity financing, but the declining stockholders' equity over time is a concern.

Cash Flow

Cash flow analysis reveals significant challenges. The company has negative operating and free cash flows, with a declining trend in free cash flow growth. The high free cash flow to net income ratio indicates reliance on non-operational cash sources. The negative operating cash flow to net income ratio further underscores operational inefficiencies.

Breakdown	TTM	Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement
Total Revenue	63.80M	64.11M	60.42M	55.11M	44.07M	41.66M
Gross Profit	27.59M	26.56M	24.41M	24.19M	18.42M	18.38M
EBITDA	-17.80M	-15.93M	-18.39M	-319.50K	309.00K	2.37M
Net Income	-19.63M	-19.02M	-21.18M	-2.93M	700.00K	-1.70M
Balance Sheet
Total Assets	61.46M	86.06M	91.55M	101.12M	77.23M	55.19M
Cash, Cash Equivalents and Short-Term Investments	10.57M	29.84M	43.47M	63.14M	47.18M	24.70M
Total Debt	7.55M	13.92M	8.42M	9.38M	10.01M	11.11M
Total Liabilities	38.14M	45.17M	34.63M	29.49M	27.17M	28.95M
Stockholders Equity	23.32M	40.90M	56.92M	71.63M	50.05M	26.25M
Cash Flow
Free Cash Flow	-12.90M	-17.68M	-18.97M	-5.21M	2.80M	1.65M
Operating Cash Flow	-10.00M	-13.58M	-14.68M	-3.02M	4.45M	2.25M
Investing Cash Flow	-2.90M	-4.12M	-4.34M	-2.38M	-1.64M	-2.29M
Financing Cash Flow	-1.19M	4.63M	-911.00K	21.74M	20.27M	3.65M

EDAP TMS Technical Analysis

• Technical Analysis Sentiment: Positive
• Last Price: 4.20
• 50DMA: Positive
• 100DMA: Positive
• 200DMA: Positive
• MACD: Positive
• RSI: Neutral
• STOCH: Negative

Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For EDAP, the sentiment is Positive. The current price of 4.2 is above the 20-day moving average (MA) of 3.89, above the 50-day MA of 3.14, and above the 200-day MA of 2.21, indicating a bullish trend. The MACD of 0.28 indicates Positive momentum. The RSI at 65.59 is Neutral, neither overbought nor oversold. The STOCH value of 82.36 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for EDAP.

EDAP TMS Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
FONR	66 Neutral	$117.62M	16.85	4.34%	―	3.36%	-21.15%
XTNT	66 Neutral	$82.88M	58.04	3.64%	―	16.88%	―
APYX	60 Neutral	$164.94M	-11.03	-172.18%	―	-1.32%	55.62%
EDAP	54 Neutral	$157.05M	-7.23	―	―	―	―
Sector *	51 Neutral	$7.86B	-0.30	-43.30%	2.27%	22.53%	-2.21%
NSPR	47 Neutral	$66.95M	-1.88	-87.61%	―	14.04%	-0.65%
ICCM	45 Neutral	$41.98M	-2.39	-157.91%	―	-18.96%	8.98%

EDAP TMS Corporate Events

EDAP TMS Announces Record 2025 HIFU Revenue, 2026 Outlook

On January 12, 2026, EDAP TMS reported select preliminary unaudited results indicating record high-intensity focused ultrasound (HIFU) revenue for both the fourth quarter and full year 2025, driven by strong global demand for its Focal One systems and rising procedure volumes, particularly in the United States. Fourth-quarter 2025 worldwide HIFU revenue is expected between $12.9 million and $13.3 million, and annual 2025 HIFU revenue between $36.7 million and $37.2 million, while non-core distribution and ESWL operations are expected to contribute $7.9 million to $8.3 million for the quarter and $32.7 million to $33.1 million for the year. Management highlighted a record 15 Focal One placements in the quarter, a 69% year-on-year increase in annual system placements, and around 28% year-on-year growth in U.S. procedures in the fourth quarter, underscoring a growing recurring revenue base and signaling that HIFU now represents more than half of expected annual revenue. EDAP also issued initial 2026 guidance, projecting $50 million to $54 million in core HIFU revenue and $22 million to $26 million in non-core revenue, while cautioning that the figures are preliminary and subject to adjustment pending completion of year-end reporting and external review, with final 2025 results slated for release in March 2026.

The most recent analyst rating on (EDAP) stock is a Hold with a $4.00 price target. To see the full list of analyst forecasts on EDAP TMS stock, see the EDAP Stock Forecast page.

EDAP TMS Secures FDA Clearance for Enhanced Focal One HIFU System

On November 20, 2025, EDAP TMS announced that it received FDA 510(k) clearance for enhancements to its Focal One High Intensity Focused Ultrasound (HIFU) system. This clearance introduces advanced ultrasound imaging and workflow improvements, reinforcing EDAP’s leadership in robotic focal therapy for prostate cancer. The updates include a new imaging engine that supports real-time visualization and the potential for AI-driven algorithms, marking a significant technical milestone for the company. This development is expected to strengthen EDAP’s market position and commitment to innovation in the field.

The most recent analyst rating on (EDAP) stock is a Hold with a $2.00 price target. To see the full list of analyst forecasts on EDAP TMS stock, see the EDAP Stock Forecast page.

EDAP TMS Highlights Growth in Prostate Cancer Treatment with Focal One HIFU

On November 18, 2025, EDAP TMS S.A. released a report highlighting the significant market opportunity for its Focal One Robotic High-Intensity Focused Ultrasound (HIFU) technology in treating prostate cancer. The company emphasized its strong clinical evidence and superior functional outcomes compared to traditional treatments, positioning Focal One as a leading option in the evolving prostate cancer treatment landscape. This strategic focus is expected to drive growth and expand the company’s presence in the global prostate cancer market.

The most recent analyst rating on (EDAP) stock is a Hold with a $2.00 price target. To see the full list of analyst forecasts on EDAP TMS stock, see the EDAP Stock Forecast page.

EDAP TMS Reports Strong Q3 2025 Results and Secures EIB Credit Facility

EDAP TMS reported a significant 49% year-over-year increase in HIFU revenue for the third quarter of 2025, driven by a 167% rise in Focal One system placements and a 15% growth in U.S. procedures. The company also secured a €36 million credit facility from the European Investment Bank to support the expansion of its Focal One platform. Additionally, EDAP’s recent achievements include receiving an industry award for innovation and conducting a successful prostate cancer awareness campaign, which has enhanced its market presence and stakeholder engagement.

The most recent analyst rating on (EDAP) stock is a Hold with a $2.00 price target. To see the full list of analyst forecasts on EDAP TMS stock, see the EDAP Stock Forecast page.