Theraclion

What Theraclion does

Theraclion is a French MedTech company that designs, develops, and commercializes non-invasive robotic High-Intensity Focused Ultrasound (HIFU) platforms for the treatment of varicose veins, thyroid nodules, and breast fibroadenoma. Founded in 2004 and listed on Euronext Growth Paris (ticker: ALTHE), the company's product portfolio centers on three commercial systems: SONOVEIN, the first robotic non-invasive echotherapy platform for varicose veins (currently offered as SONOVEIN HD with SuperSonic Imagine imaging); ECHOPULSE, a robotic HIFU system for thyroid nodules and breast fibroadenoma; and EPack, a patented single-use disposable required for every treatment that ensures cooling and acoustic coupling. The company additionally maintains CURE-OP, a research-stage platform combining HIFU with radiotherapy for oncology applications, developed in collaboration with academic partners in Germany and the US.

The underlying technology combines a 7-axis medical-grade robotic positioning system with continuous real-time ultrasound imaging and proprietary treatment-planning algorithms — including a speckle-tracking temperature-estimation algorithm validated to ±0.5°C. Theraclion generates revenue primarily through capital equipment sales of SONOVEIN and ECHOPULSE systems to hospitals and specialized treatment centers across 10+ countries, supplemented by recurring consumable revenue from EPack and ongoing service contracts. Distribution is hybrid: direct enterprise field sales supplemented by exclusive distribution partners such as EDAP TMS (France) and a joint venture with Furui (China). Customer concentration is diffuse across more than 15 treatment-center countries, with named collaborations including the University of Virginia Cancer Center for oncology research.

Commercially, Theraclion has accumulated a dense regulatory moat in 2025-2026: MDR certification under EU 2017/745 for SONOVEIN (September 2025), successful completion of a US FDA pivotal study with 96.8% occlusion efficacy (2025), Chinese GB 9706.1-2020 safety certification (October 2025), and an AMA Category III CPT code for US reimbursement (2026). The company is loss-making and remains dependent on equity capital — most recently an oversubscribed €5.99M raise in May 2026 extending the cash runway to June 2027 to support US launch preparation and continued European commercial expansion. With 11-50 employees, the company remains a small-cap, pre-commercial-scale MedTech whose near-term trajectory is contingent on converting accumulated regulatory approvals into recurring device and EPack consumable revenue.

Name

Theraclion

Legal name

THERACLION S.A.

Website

https://theraclion.com

Company type

Public

Founded year

2004

Operating status

Operating

Headcount range

11–50 employees

Short description

French MedTech company developing non-invasive robotic High-Intensity Focused Ultrasound (HIFU) platforms — principally SONOVEIN for varicose veins and ECHOPULSE for thyroid nodules and breast fibroadenoma — sold to hospitals and treatment centers in 10+ countries, with consumable revenue from the EPack disposable.

Ownership category

akta.pro rank

Product category

Therapeutic Ultrasound Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Medical Equipment and Supplies Manufacturing (3391)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Interventional Radiology & Image-Guided Therapy Systems (HLAHABAG)

akta.pro secondary industry

Ultrasound & Echography Systems (HLAHABAD)

Keywords

• Focused ultrasound therapy
• Non-invasive medical devices
• HIFU systems
• Varicose vein treatment
• Echotherapy platforms

Headquarters

HQ city

Malakoff

HQ country

France

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Device Sales: Sale of HIFU medical equipment systems including SONOVEIN and ECHOPULSE platforms to healthcare providers and treatment centers.
2. EPack Consumables: Single-use disposable EPack products ordered before each treatment, providing recurring revenue from installed customer base.
3. Service and Maintenance: Ongoing service, training, and technical support for installed medical devices.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels6 records

Core offering

Theraclion develops and sells robotic High-Intensity Focused Ultrasound (HIFU) / echotherapy medical devices for non-invasive treatment of varicose veins (SONOVEIN), thyroid nodules and breast fibroadenoma (ECHOPULSE), supported by the single-use EPack consumable. The company also runs the CURE-OP research platform for combinational HIFU and radiotherapy cancer therapy. Customers are hospitals, vascular surgery centers, and specialized treatment centers purchasing capital equipment and recurring disposables.

Product overview

Theraclion is a French MedTech company that develops non-invasive, intelligent, robotic High-Intensity Focused Ultrasound (HIFU) platforms. The product portfolio centers on two core therapeutic devices: SONOVEIN (robotic HIFU platform for varicose veins treatment) and ECHOPULSE (echotherapy device for thyroid nodules and breast fibroadenoma). Supporting these is EPack, a single-use disposable ensuring cooling and coupling functions. SONOVEIN HD represents an enhanced imaging version of the varicose veins platform. The company is also developing CURE-OP as a research platform for combinational cancer therapy. All products are designed for non-surgical, non-invasive treatment in non-sterile environments with single-operator use.

Differentiator

Problem solved

Functional benefit

Brands

• SONOVEIN: Robotic HIFU platform for non-invasive treatment of varicose veins
• ECHOPULSE
• EPack
• CURE-OP

Products and services

• SONOVEIN SONOVEIN is the first and only robotic, 100% non-invasive echotherapy system using High-Intensity Focused Ultrasound (HIFU) for treatment of varicose veins. It requires no additional accessories (no guide wires, puncture kits or catheters), can be operated by a single person in a non-sterile environment, leaves no incisions or scars, and enables patients to resume normal activities immediately. CE marked under MDR for coagulation of blood vessels in patients with superficial vein reflux.
• SONOVEIN HD SONOVEIN HD is the newest version of Theraclion's robotic HIFU platform for varicose veins, integrating leading-edge imaging capabilities from SuperSonic Imagine. Features a 7-axis medical grade robot for maximum positioning flexibility and optimal acoustic access to target volumes. Achieved 96.8% efficacy in FDA pivotal trial.
• ECHOPULSE ECHOPULSE is the first robotic and 100% non-invasive solution for echotherapy treatment (HIFU) of thyroid nodules and breast fibroadenoma. Combines therapeutic ultrasound with a standard ultrasound beam for real-time image visualization, can be operated by a single person in a non-surgical environment, and maintains thyroid function and the integrity of breast tissue. Achieves 70% volume reduction of fibroadenoma after 12 months.
• EPack EPack is a single-use patented disposable used with both SONOVEIN and ECHOPULSE that ensures cooling and coupling functions. It protects the patient's skin during HIFU treatments and optimizes image quality. Class I medical device CE marked under Directive 93/42/EEC. Provides recurring revenue from the installed base.
• CURE-OP CURE-OP (Combinational Ultrasound Radiotherapy Enhanced Oncology Platform) is a HIFU research platform designed for combinational cancer therapy. It delivers ultrasound regimes (hyperthermia, thermal ablation, and cavitation) combined with radiotherapy. Developed in collaboration with ICCAS (University of Leipzig), Fraunhofer MEVIS, and Mediri for therapy planning, advanced imaging, and motion control. Includes speckle tracking algorithm for real-time temperature estimation with ±0.5°C accuracy.

Quantifiable outcome

• 96.8% occlusion rate in FDA pivotal trial
• +3 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability5 records

Feature6 records

Partnerships

Seven partnerships are on record, tiered core, major and minor.

• ICCAS (Innovation Center Computer Assisted Surgery)coreStrategic or Co-development Partner · 1 November 2022Part of University of Leipzig, Germany. Develops computer-aided integrative technologies and intelligent assistance systems in medicine. Responsible for robotics and radiotherapy workflow integration in CURE-OP project.
• Fraunhofer MEVIScoreStrategic or Co-development Partner · 1 November 2022German Institute for Digital Medicine developing software solutions for image and data-supported early detection, diagnosis, and therapy. Responsible for ultrasound therapy planning and advanced imaging work package.
• MediricoreStrategic or Co-development Partner · 1 November 2022German company specialized in clinical imaging, research and software development. Provides therapy visualization and motion control software modules for CURE-OP platform.
• EDAP TMS FrancemajorChannel Partner/ Reseller/ Distributor · 9 October 2017Exclusive distribution agreement for Theraclion products in France. EDAP TMS is a established medical technology company specializing in therapeutic ultrasound.
• University of TübingenminorStrategic or Co-development Partner · 1 September 2017Clinical research partnership for HIFU treatment studies and preliminary clinical data generation.
• University of Virginia (UVA) Cancer CentermajorStrategic or Co-development Partner · 1 June 2017Ongoing collaboration for cancer treatment research using Theraclion's HIFU technology. Includes early-stage breast cancer study and immunotherapy combination trials.
• Furui (Joint Venture)majorStrategic or Co-development Partner · 1 April 2017Joint venture partnership established in China for sales and clinical development in Asian markets.

Scale indicators8 records

Recent moves7 records

Expansion highlights7 records

Broad incumbents

• Medtronic: Global medtech incumbent with VenaSeal closure system and other varicose vein therapies. Competes with SONOVEIN in the same phlebology indication with deep sales coverage and established reimbursement infrastructure.
• Siemens Healthineers: Global incumbent in diagnostic and therapeutic imaging including ultrasound. Relevant broad incumbent whose imaging integration capabilities could complement or compete with Theraclion's image-guided HIFU positioning in hospital settings.
• Boston Scientific: Large incumbent in vascular intervention including endovenous therapies (laser and RF ablation systems for varicose veins). Direct competitive overlap with SONOVEIN in phlebology from an established medtech player with superior distribution.
• Philips Healthcare: Global incumbent in medical imaging with therapeutic ultrasound capabilities and a large installed base across hospitals. Relevant as a broad competitor and potential channel partner for image-guided therapy workflows where Theraclion's HIFU operates.

Direct peers

• SonaCare Medical (Sonablate): U.S.-based manufacturer of Sonablate high-intensity focused ultrasound systems for prostate tissue ablation. Direct peer in therapeutic HIFU with overlapping clinical and regulatory positioning.
• EDAP TMS: French-listed therapeutic ultrasound company (also Euronext) that develops HIFU devices — most notably Focal One for prostate cancer — and is Theraclion's exclusive French distribution partner. Directly comparable as a publicly-listed European HIFU device manufacturer targeting similar physician offices.
• Insightec: Israel-based developer of MR-guided focused ultrasound systems (Exablate Neuro, Exablate Prostate) for incisionless therapeutic procedures. Most established commercial peer in non-invasive focused ultrasound, directly comparable in core technology category.
• Chongqing Haifu Medical Technology: Chinese pioneer in HIFU technology with a broad therapeutic ultrasound platform used across multiple oncology and non-oncology indications. Direct competitor in HIFU, particularly relevant given Theraclion's China JV and GB certification strategy.
• Profound Medical: Canada-based developer of TULSA-PRO, a transurethral HIFU platform for prostate tissue ablation. Direct peer in therapeutic HIFU with similar regulatory pathway challenges and comparable physician-office deployment model.

Emerging players

• SuperSonic Imagine: French developer of advanced ultrasound imaging technology whose imaging engine is integrated into Theraclion's SONOVEIN HD platform. A technology supplier and emerging player in diagnostic/therapeutic ultrasound, closely entwined with Theraclion's product roadmap.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/theraclion
• Instagraminstagram.com/sonovein.official
• Facebookfacebook.com/303792825050

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 records

Subsidiaries1 record

Funding overview

Funding rounds4 records

Investors2 records

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 Theraclion