EDAP TMS

What EDAP TMS does

EDAP TMS S.A., now operating as FocalTherics (NASDAQ: FOCL, formerly EDAP), is a French medical device company that has pivoted from a diversified therapeutic ultrasound portfolio to a pure-play robotic focal therapy business. The company develops and commercializes the Focal One platform — a robotic High Intensity Focused Ultrasound (HIFU) system for non-invasive prostate tissue ablation. Focal One combines a five-degrees-of-freedom robotic positioning system with submillimetric precision, a Dynamic Focusing Probe that fuses real-time ultrasound imaging with HIFU energy delivery, and the proprietary HIFUsion open-platform software that performs elastic fusion of MRI and 3D biopsy maps for treatment planning. The platform is sold as the Focal One and Focal One i systems, with the Focal One Eye variant launched in the U.S. in August 2025. Headquartered in Lyon, France with a U.S. commercial office in Austin, Texas, the company holds regulatory clearances in the U.S., Europe, Canada, Korea, Russia, Brazil, and other markets, supported by 154 peer-reviewed publications and major clinical studies including HIFI, FARP, and HIFI-2.

The company generates revenue through direct enterprise capital sales of Focal One systems to hospital urology departments and specialty urology clinics, supplemented by an operating lease option and a recurring procedure-driven disposables stream. The installed base reached 87 systems at year-end 2025 (52% CAGR over 2021-2025), with procedures growing at a 44% CAGR. FY2025 HIFU revenue was €33.1M ($37.4M, +39% YoY) and Q1 2026 total revenue hit a record $17.8M (+25% YoY) including $11.6M of HIFU (+78% YoY). Management has guided 2026 total revenue to $72-80M, with HIFU specifically at $50-54M. The company is reclassifying its legacy ESWL and Distribution segments as discontinued operations from Q2 2026 to focus capital on robotic HIFU, secured a €36M debt facility from the European Investment Bank in October 2025, and signed a letter of intent with Telix Pharmaceuticals in May 2026 to combine Focal One with PSMA PET imaging for image-guided focal therapy.

Name

EDAP TMS

Legal name

EDAP TMS S.A.

Website

https://edap-tms.com

Company type

Public

Founded year

1979

Operating status

Operating

Headcount range

101–250 employees

Short description

EDAP TMS, now operating as FocalTherics (NASDAQ: FOCL), is a French medical device company that develops and sells the Focal One robotic HIFU system for non-invasive prostate tissue ablation, serving hospital urology departments and specialty urology clinics worldwide through direct enterprise sales, operating leases, and procedure-driven disposables.

Ownership category

akta.pro rank

Product category

Therapeutic Ultrasound Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Surgical Appliance and Supplies Manufacturing (339113)

SIC

Surgical & Medical Instruments & Apparatus (3841), Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Surgical Robotics & Computer-Assisted Surgery Platforms (HLAHADAF)

akta.pro secondary industries

Surgical Navigation, Tracking & Intraoperative Guidance (Ortho/Neuro/ENT) (HLAHADAG), Interventional Radiology & Image-Guided Therapy Systems (HLAHABAG)

Keywords

• Robotic HIFU systems
• Prostate tissue ablation
• Medical ultrasound devices
• Focal therapy equipment
• Urology medical devices

Headquarters

HQ city

Vaulx-en-velin

HQ country

France

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Supply Chain, Technology or R&D, Personnel, Marketing or Sales, Operations, Infrastructure

Revenue model

1. HIFU Capital Equipment Sales: Sale of Focal One robotic HIFU systems to hospitals and clinics. The company sold 69% more Focal One systems year-over-year in 2025 (with 14 systems sold in Q4 alone, comprising 14 cash sales and one operating lease). Q1 2026 saw 11 capital sales.
2. Procedures and Disposables: Recurring revenue from procedures performed using Focal One systems. Worldwide disposables revenue grew 43% year-over-year. 53% growth in U.S. Focal One procedures in Q1 2026.
3. Operating Lease: Focal One systems placed under operating lease arrangements, providing recurring revenue stream.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

EDAP TMS (now operating as FocalTherics) designs, manufactures, and sells the Focal One robotic High-Intensity Focused Ultrasound (HIFU) platform for non-invasive prostate tissue ablation. The company sells capital equipment (Focal One systems) directly to hospitals and urology clinics, generates recurring revenue from procedure-related disposables, and places systems via operating leases.

Product overview

EDAP TMS (now operating as FocalTherics) offers the Focal One® platform, a comprehensive robotic HIFU system for non-invasive prostate tissue ablation. The core Focal One® HIFU Robotic System integrates several key components: the Robotic Positioning System providing submillimetric precision with five degrees of freedom, the HIFUsion® open-platform fusion software for MRI and 3D biopsy mapping, the Dynamic Focusing Probe combining real-time ultrasound imaging with HIFU energy delivery, and an Integrated Workstation for OR compatibility. The company also offers the Focal One i as an enhanced version of the platform. The company is transitioning away from non-core ESWL (Extracorporeal Shock Wave Lithotripsy) and Distribution segments to focus exclusively on its high-growth robotic HIFU business.

Differentiator

Problem solved

Functional benefit

Brands

• Focal One: Robotic HIFU system for non-invasive prostate tissue ablation using high-intensity focused ultrasound technology
• Focal One i
• HIFUsion

Products and services

• Focal One HIFU Robotic System Flagship robotic High-Intensity Focused Ultrasound (HIFU) system used by urologists and hospitals to non-invasively ablate prostate tissue while sparing healthy surrounding tissue, with submillimetric precision and real-time ultrasound imaging.
• Focal One i Advanced iteration of the Focal One robotic HIFU platform with enhanced capabilities for non-invasive ablation of prostate tissue controlled by urologists.
• Focal One Eye Focal One Eye system launched in the U.S. market in August 2025 for non-invasive prostate tissue ablation using HIFU technology.

Quantifiable outcome

• 71% androgen deprivation therapy-free survival at 30 months
• +6 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

One partnership is on record.

• Telix PharmaceuticalscoreStrategic or Co-development Partner · 14 May 2026EDAP TMS entered into a non-binding letter of intent with Telix Pharmaceuticals to explore joint clinical research combining Focal One Robotic HIFU with Telix's PSMA PET imaging products for prostate cancer management. The collaboration aims to optimize treatment planning, deliver image-guided focal therapy, and monitor patient responses in both primary and salvage treatment settings following radiation therapy. The parties may explore clinician educational programs and clinical studies. No financial commitments have been made and there is no assurance that definitive agreements will result from this initial collaboration.

Scale indicators19 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• Profound Medical Corp: Profound Medical develops the TULSA-PRO system, an MRI-guided transurethral ultrasound ablation platform for prostate tissue — the closest direct competitor to Focal One in robotic, image-guided prostate ablation. Both target the same focal-therapy indication and similar urology customer base.
• SonaCare Medical: SonaCare Medical commercializes the Sonablate system, a high-intensity focused ultrasound (HIFU) platform for transrectal prostate tissue ablation. It competes head-to-head with Focal One in the same focal-therapy indication and overlapping urology customer base.

Emerging players

• HistoSonics: HistoSonics develops the Edison histotripsy platform, a non-invasive, non-thermal focused-ultrasound tissue destruction technology that overlaps with HIFU in mechanism and prostate indication. It is an emerging, venture-backed competitor entering the focal-therapy space that could pressure HIFU incumbents.

Broad incumbents

• Insightec: Insightec commercializes Exablate, a MR-guided focused ultrasound (MRgFUS) platform with multiple clinical applications including prostate and other oncology indications. It is a broader focused-ultrasound incumbent with overlapping technology roots but a wider indication portfolio than Focal One.
• Boston Scientific: Boston Scientific is a large diversified medical-device company with a urology portfolio including Rezūm water-vapor thermal therapy for BPH and other prostate-treatment technologies. It competes indirectly by offering alternative minimally invasive urology treatments within the same hospital purchasing workflows.
• AngioDynamics: AngioDynamics manufactures and sells a portfolio of minimally invasive and ablation devices used across multiple specialties, including interventional oncology. While it does not specialize in HIFU, it overlaps with FocalTherics in image-guided tissue ablation and hospital oncology customers.
• Varian (Siemens Healthineers): Varian, a Siemens Healthineers company, is a global leader in radiation oncology (including prostate cancer) with CyberKnife and conventional linear accelerators. It represents the entrenched radical-treatment incumbent that focal therapies like Focal One are displacing or substituting for in select patients.
• Elekta: Elekta is a major provider of radiation therapy and radiosurgery systems used in prostate cancer treatment. It competes indirectly with Focal One by representing the standard-of-care radical treatment against which focal therapy is benchmarked.
• Medtronic: Medtronic is a diversified medical-device leader with ablation, surgical, and urology-adjacent product lines. While not a focused HIFU competitor, it competes broadly in the same hospital capital-equipment purchasing cycles and minimally invasive procedure categories.

Regional players

• HealthTronics: HealthTronics provides urology-focused capital equipment, services, and lithotripsy solutions across North America. It is a regional urology services and devices player that intersects with FocalTherics in BPH and stone management devices and shares similar hospital-urology customers, though it does not directly compete in HIFU.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/edaptms
• Facebookfacebook.com/edaptmscompany

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds2 records

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about EDAP TMS