EDAP TMS
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.
- Company typePublic
- Founded1979
- HeadquartersVaulx-en-velin, France
- Headcount101–250
- GTM typeB2B
- OfferingHardware or Manufacturing
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.
EDAP TMS firmographics
Firmographics- 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
EDAP TMS industry classification
Industry- 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
Where EDAP TMS is headquartered
LocationHeadquarters
- HQ city
- Vaulx-en-velin
- HQ country
- France
- HQ region
- Europe
Offices2 records
Markets served
EDAP TMS business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Supply Chain, Technology or R&D, Personnel, Marketing or Sales, Operations, Infrastructure
Revenue model
- 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.
- 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.
- 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
EDAP TMS product offering
Product offeringCore 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
Companies that use EDAP TMS
Customer profileNamed customers4 records
Segments3 records
Ideal customer profiles2 records
EDAP TMS technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
EDAP TMS partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- Telix PharmaceuticalscoreEDAP 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
EDAP TMS competitors and assessment
Company assessmentDirect 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
EDAP TMS social profiles
Digital presenceEDAP TMS financial estimates
Financial estimateRevenue estimate
Valuation estimate
EDAP TMS leadership team
Management profileNumber of profiles
Profiles4 records
EDAP TMS funding detail
Funding detailFunding overview
Funding rounds2 records
Investors1 record
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
EDAP TMS M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about EDAP TMS
What does EDAP TMS do?
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.
Is EDAP TMS a public or private company?
EDAP TMS is a public company. It is classified as public and is currently operating.
When was EDAP TMS founded?
EDAP TMS was founded in 1979. It employs 101 to 250 people.
Where is EDAP TMS based?
EDAP TMS is headquartered in Vaulx-en-velin, France, in the Europe region.
How does EDAP TMS make money?
Three revenue lines are on record. HIFU Capital Equipment Sales are the primary driver. The others are procedures and Disposables and operating Lease.
Who are EDAP TMS's main competitors?
Direct peers on record are Profound Medical Corp and SonaCare Medical. HistoSonics is listed as an emerging player. Broad incumbents are Insightec, Boston Scientific, AngioDynamics, Varian (Siemens Healthineers), Elekta and Medtronic. HealthTronics is listed as a regional player.
Does EDAP TMS have an API?
No public API is recorded for EDAP TMS.
What industry is EDAP TMS in?
EDAP TMS's product category is Therapeutic Ultrasound Medical Devices. Its primary akta.pro industry code is HLAHADAF, Surgical Robotics & Computer-Assisted Surgery Platforms, with a secondary code of HLAHADAG, Surgical Navigation, Tracking & Intraoperative Guidance (Ortho/Neuro/ENT). Its NAICS code is 334510 and its SIC code is 3841.