EDAP TMS (EDAP) AI Stock Analysis

• Market Cap: $75.91M
• Dividend Yield: N/A
• Average Volume (3M): 61.70K
• Price to Earnings (P/E): ―
• Beta (1Y): 1.02
• 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: 0.70
• Enterprise Value/Revenue: 0.83
• Enterprise Value/Gross Profit: 1.93
• Enterprise Value/Ebitda: -2.99
• 1Y Price Target: $14.00
• Price Target Upside: 478.51% Upside
• Rating Consensus: Moderate Buy
• Number of Analyst Covering: 1
• EPS Forecast (FY): N/A
• Revenue Forecast (FY): N/A

• Rating: 52 Neutral
• Price Target: $2.50 ▲(3.31% Upside)

EDAP TMS's overall score is driven by strong growth in its core HIFU business, but is offset by financial challenges, particularly in profitability and cash flow. Technical indicators show positive momentum, but valuation remains a concern due to ongoing losses.

Positive Factors

HIFU Revenue Growth

Significant HIFU revenue growth indicates strong demand and market acceptance, supporting long-term business expansion and profitability.

Reimbursement Progress

Improved reimbursement coverage enhances market accessibility and adoption of EDAP's technologies, boosting revenue potential and competitive positioning.

EIB Credit Facility

The credit facility supports R&D and expansion efforts, strengthening EDAP's financial position and enabling strategic growth in medical technology.

Negative Factors

Operating Loss

Continued operating losses highlight challenges in achieving profitability, which may impact long-term financial sustainability and investment capacity.

Cash Flow Challenges

Decreasing cash reserves indicate potential liquidity issues, limiting EDAP's ability to invest in growth and manage operational expenses effectively.

Tariff Impact

Tariff impacts increase costs and reduce margins, potentially affecting EDAP's competitiveness and profitability in key markets.

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

EDAP TMS faces financial challenges, particularly in profitability and cash flow management. While revenue growth is a positive sign, the company struggles with operational efficiency and generating shareholder returns. The balance sheet remains relatively stable, but improvements in cash flow and profitability are essential for long-term sustainability.

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: 2.42
• 50DMA: Positive
• 100DMA: Positive
• 200DMA: Positive
• MACD: Negative
• RSI: Neutral
• STOCH: Neutral

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 2.42 is above the 20-day moving average (MA) of 2.14, above the 50-day MA of 2.25, and above the 200-day MA of 1.99, indicating a bullish trend. The MACD of 0.04 indicates Negative momentum. The RSI at 60.17 is Neutral, neither overbought nor oversold. The STOCH value of 70.18 is Neutral, 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
APYX	60 Neutral	$164.47M	―	-172.18%	―	-1.32%	55.62%
XTNT	60 Neutral	$87.46M	61.18	3.64%	―	16.88%	―
FONR	59 Neutral	$88.78M	12.72	4.34%	―	3.36%	-21.15%
EDAP	52 Neutral	$75.91M	-3.54	―	―	―	―
Sector *	51 Neutral	$7.86B	-0.30	-43.30%	2.27%	22.53%	-2.21%
NSPR	47 Neutral	$88.66M	-2.52	-87.61%	―	14.04%	-0.65%
ICCM	41 Neutral	$48.14M	―	-157.91%	―	-18.96%	8.98%

EDAP TMS Corporate Events

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.

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.

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.

EDAP TMS Secures €36 Million EIB Credit Facility for Medical Tech Advancements

On October 17, 2025, EDAP TMS S.A. entered into a €36 million credit facility agreement with the European Investment Bank to fund its research and development projects in robotic medical technology. This financing will support the company’s efforts to enhance its high-intensity focused ultrasound technology, which is used to treat conditions like prostate cancer and endometriosis. The credit facility is structured in three tranches, each with specific conditions for disbursement, and includes a warrant agreement for issuing warrants to the EIB. This strategic financial move is expected to bolster EDAP TMS’s position in the medical technology industry and advance its innovative treatment solutions.

EDAP TMS Focuses on Robotic HIFU Leadership in Prostate Cancer

EDAP TMS S.A. has announced its strategic focus on becoming the global market leader in robotic HIFU focal therapy for prostate cancer, a move supported by compelling clinical evidence and increasing demand. The company’s Focal One technology is highlighted as a superior treatment option, offering better functional outcomes compared to traditional methods like radical prostatectomy, and is positioned to drive a paradigm shift in prostate cancer treatment.

EDAP TMS Secures HIFU Reimbursement for Prostate Cancer in France

On September 8, 2025, EDAP TMS announced that the French Ministry of Health has approved reimbursement for the High Intensity Focused Ultrasound (HIFU) procedure for prostate cancer treatment in France. This reimbursement milestone allows broader patient access to the Focal One Robotic HIFU procedure, marking a significant commercial achievement for EDAP TMS. The decision is expected to enhance the company’s market position in Europe and potentially accelerate similar approvals in other countries, benefiting stakeholders by expanding treatment options for prostate cancer.

EDAP TMS Reports Record Q2 2025 HIFU Growth and Strategic Expansion Plans

EDAP TMS reported a strong performance in the second quarter of 2025, highlighted by a 140% year-over-year growth in net placements of its Focal One Robotic HIFU Systems and a 76.8% increase in HIFU revenue. The company also executed a letter of intent for a 36 million Euro credit facility with the European Investment Bank to support further growth and strategic expansion of its HIFU business. EDAP raised its 2025 HIFU revenue growth guidance to a range of 26% to 34%, reflecting the increasing demand for its Focal One platform. Despite a decline in its non-core business revenue, the company continues to focus on expanding its HIFU operations, supported by significant clinical evidence and growing adoption in the urology community.

EDAP TMS Secures EUR 36 Million Credit Facility for Growth

On August 26, 2025, EDAP TMS announced a letter of intent for a EUR 36 million credit facility with the European Investment Bank. This funding aims to support the expansion of Focal One® Robotic HIFU in prostate cancer treatment and the development of new clinical indications. The credit facility is expected to close by the end of 2025, enhancing EDAP’s financial position and enabling broader access to its innovative technologies.