Welcome to our dedicated page for Edap Tms SEC filings (Ticker: EDAP), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
Trying to pinpoint HIFU sales trends or FDA clearance milestones inside EDAP’s dense disclosures? The company’s multi-division model—robotic high-intensity focused ultrasound, extracorporeal lithotripsy, and third-party distribution—produces technical documents packed with clinical data and global regulatory notes, making EDAP SEC filings explained simply a real need.
Stock Titan decodes every document as soon as it hits EDGAR. Our AI-powered summaries turn an EDAP annual report 10-K simplified into a five-minute read, flagging segment revenue, backlogged orders, and device approval status. Want the latest quarter? The EDAP quarterly earnings report 10-Q filing arrives with instant ratio analysis and plain-English commentary. Form types are mapped to real investor questions:
- EDAP 8-K material events explained for sudden trial outcomes
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Need real-time alerts? EDAP Form 4 insider transactions real-time pings you the moment executives trade. Curious about the impact of a new Focal One installation? Our EDAP earnings report filing analysis connects revenue changes to installed-base growth. From understanding EDAP SEC documents with AI to tracking EDAP executive stock transactions Form 4, you can move from document dump to decision in minutes—while retaining the original filing for audit trails.
EDAP TMS S.A. (EDAP) reported that the U.S. Food and Drug Administration has granted 510(k) clearance for new ultrasound imaging and workflow enhancements to its Focal One High Intensity Focused Ultrasound (HIFU) system used in robotic focal therapy for prostate cancer. The clearance covers advanced ultrasound imaging, streamlined treatment planning, and an optimized user interface for the recently launched Focal One i platform.
EDAP states that the next generation ultrasound imaging engine provides real-time visualization and supports the potential development of AI-driven algorithms to assist surgeons with tissue ablation visualization and treatment evaluation. Management describes this as an important technical milestone that further strengthens Focal One’s product roadmap and reinforces its global leadership positioning in focal therapy.
EDAP TMS (EDAP) highlights its position as a global leader in robotic high-intensity focused ultrasound (HIFU) for prostate cancer, BPH and endometriosis, supported by growing clinical use and reimbursement. The company reports revenue of
EDAP remains loss-making, with operating loss of
EDAP TMS (EDAP) reported third-quarter 2025 results highlighting continued momentum in its HIFU franchise. HIFU revenue was
Profitability metrics improved: gross profit was
Management reiterated 2025 guidance: core HIFU revenue growth of
EDAP TMS SA reported strong commercial momentum in HIFU (high-intensity focused ultrasound), with Focal One net placements up +140% year-over-year and HIFU revenue up 76.8% year-over-year. Management raised 2025 HIFU revenue growth guidance to a 26%–34% range from a prior 16%–25% range, and executed a letter of intent with the European Investment Bank for a €36 million credit facility to support HIFU growth and strategic expansion.
The company announced it will become a U.S. domestic filer effective January 1, 2026, beginning SEC reporting and Nasdaq requirements. Additional milestones include presentation of positive 3-year randomized controlled trial outcomes for focal ablation versus radical prostatectomy and the launch of the new Focal One i Robotic HIFU System.
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