Regulatory News:
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Sonovein®, the first and only non-invasive varicose veins treatment
THERACLION (ISIN: FR0010120402; Mnemo: ALTHE), an innovative company developing Sonovein®, a robotic platform for non-invasive High-Intensity Focused Ultrasound (HIFU) varicose vein treatment, reviews its business for S1 2025.
- Sales of consumables (recurring revenue) up 30% compared to 2024
- New treatment centers opened in Bulgaria and Spain
- Appointment of a new business manager and acceleration of commercial activities
- On-schedule completion of the follow-up period for the pivotal FDA clinical trial
Martin Deterre, CEO of Theraclion, states: "In early 2025, Theraclion stepped up Sonovein's activity. In June, the final 12-month follow-ups for patients in the pivotal FDA-approved clinical trial were completed on-schedule. We are now awaiting the final results, which we expect to publish in September. Theraclion has also entered a business development phase: building a sales and marketing team, opening two new Sonovein treatment centers, and achieving significant growth in recurring revenue all of which promise the achievement of our ambitious goals."
Commercial activity acceleration
As part of its business development, Theraclion is actively building its sales and marketing team. In May 2025, Thibault Le Normand joined the company as Chief Business Officer to boost sales in the Middle East and product placements (PPUs) of Sonovein in Europe. With over a decade of experience in international development of medical devices, Thibault Le Normand brings valuable expertise to this strategic growth phase.
At the same time, the technological credibility and clinical maturity of Sonovein have been further demonstrated by the publication of new scientific articles as well as by over a dozen presentations at major international congresses by renowned physicians using the device. Sonovein's international profile has also increased through Theraclion's participation in congresses, such as Vein in Venice (April, Venice), Venous Symposium (May, New York), and the European Venous Forum (June, Krakow). This outreach effort was supported by the launch of a new product identity and a new website, www.sonovein.com, giving Sonovein a new brand image that reflects innovation, clinical excellence, and ambition.
In addition, two new product placement (PPU) contracts for Sonovein have been signed in Bulgaria and Spain, stepping up Theraclion's presence in Europe and expanding the installed base of the technology.
Revenue for S1 2025
In K€ | 06/30/2025 | 06/30/2024 | Var. |
Revenue | 835 | -238 | |
from the sale of components and systems | 309 | -572 | |
from the sale of consumables | 372 | 287 | 30% |
from the sale of services | 153 | 46 | 232% |
Other operating revenue | 17 | 138 | -88% |
of which Veins | 832 | 442 | |
of which Breast and Thyroid | 3 | -680 | |
Total operating revenue | 852 | -100 |
Theraclion's revenue for S1 2025 was €835K, up 89% compared to 2024 (€442K) (prior to the non-recurring adjustment of €680K related to the cancellation of Echopulse system sales in 2024).
Consumables, which include recurring revenues from PPUs, was up 30% compared to S1 2024. Service revenues were up 232% over the same period. This strong momentum is a key indicator of increasing use of Sonovein by treatment centers and reflects the technology's sustained traction in the field.
Combined, consumables and services representing recurring revenue was up 57% compared to 2024.
Progress of the pivotal FDA clinical trial
In the USA, the pivotal FDA-approved study for SONOVEIN® reached a major milestone in June 2025 with the on-schedule completion of the 12-month post-treatment patient follow-ups. Data analysis is currently underway, with results expected in September.
Submission of the marketing authorization application to the FDA is planned for Fall 2025, with potential approval estimated for Q2 2026, subject to the FDA's processing time. This progress marks a critical strategic milestone in the work to access the world's largest market for venous disease treatment.
Next financial publication:
Theraclion will publish its interim financial results on October 29, 2025.
About Theraclion
Theraclion is a French MedTech company committed to developing a non-invasive alternative to surgery through the innovative use of focused ultrasound.
High Intensity Focused Ultrasound (HIFU) does not require incisions or an operating room, leaves no scars, and patients can immediately resume their routines. HIFU treatment concentrates therapeutic ultrasounds on an internal focal point from outside the body.
Theraclion is developing SONOVEIN®, a CE-marked, a robotic platform for HIFU varicose vein treatment, which could replace millions of surgical procedures every year. In the USA, SONOVEIN® is an investigational device limited to investigational use; it is not available for sale in the USA.
Based in Malakoff (Paris), the Theraclion team comprises some 30 people, most of them involved in technological and clinical development.
For more information, visit www.theraclion.com and follow LinkedIn account
Theraclion is listed on Euronext Growth Paris
Eligible for the PEA-PME scheme
Mnemonic: ALTHE ISIN code: FR0010120402
LEI: 9695007X7HA7A1GCYD29
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Contacts:
Theraclion contact
Martin Deterre
Chief Executive Officer
contact@theraclion.com
