THERACLION ANNOUNCES SONOVEIN FDA SUBMISSION
FOLLOWING A STRONG YEAR OF REGULATORY AND
CLINICAL ACHIEVEMENTS
Malakoff, December 9, 2025, 6:30 pm - THERACLION (ISIN: FR0010120402; Mnemo: ALTHE), an
innovative company developing Sonovein®, a robotic platform for non-invasive High-Intensity
Focused Ultrasound (HIFU) varicose vein treatment, reports today the key regulatory and clinical
communication achievements of the past year across congresses, publications, and expert
presentations.

Regulatory update: FDA submission
Theraclion announces that the full dataset from the U.S. Food and Drug Administration pivotal
study has been submitted to the FDA on schedule as part of the De Novo clearance process for
Sonovein®. Based on typical FDA review timelines for comparable devices, a decision is
anticipated around mid-2026. FDA clearance would authorize U.S. commercialization, giving
access to the largest varicose vein treatment market.

Additional regulatory progress in Europe and China
In 2025, Sonovein® also achieved key regulatory milestones, including EU MDR certification and
compliance with China’s GB 9706.1-2020 standard, strengthening its pathway to long-term
commercialization in Europe and future market access in China.

New publications and scientific evidence
In 2025, several peer-reviewed publications further strengthened the clinical evidence
supporting Sonovein® and its non-invasive HIFU technology, including:
• Rodríguez Carvajal et al., in Phlebology, found 94% to 97% efficacy on 164 veins at 12 months
• Izquierdo Lamoca et al., in Journal of Vascular Surgery: Venous and Lymphatic Disorders,
demonstrated 95% efficacy on 204 legs at 24 months
• Casoni et al., in Phlebology, reported 100% efficacy at 12 months on 25 perforator veins
These results were complemented by Theraclion’s FDA pivotal study, which confirmed strong
durable efficacy with 96.8% occlusion rate at 12 months, and an excellent safety profile across
four international centers.

A year marked by strong congress presence
In 2025, Sonovein® was featured in 16 international congresses, strengthening its visibility among
vascular surgeons, phlebologists and vein-care specialists worldwide. This included 2 major




Page 1 sur 2
congresses in the U.S.—the Venous Symposium and VEITHsymposium in New York., 4 events in
France, and 8 congresses across the rest of Europe.
The Theraclion Sales & Marketing team was present with a booth at 7 of the 15 major
conferences, ensuring direct engagement with physicians, hospital administrators, and potential
new centers. The Sonovein’s disruptive value proposition combined with demonstrated efficacy
was very well received by the market.




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. HIFU
treatment concentrates therapeutic ultrasounds on an internal focal point from outside the
body.
Theraclion is developing Sonovein®, a MDR CE-marked, robotic HIFU platform for varicose vein
treatment, that could replace millions of surgical procedures every year. To date, Sonovein® has
been adopted by more than a dozen centers worldwide and used in over 3,500 procedures. In
the U.S., Sonovein® is not available for sale.
For more information, please visit www.theraclion.com and follow the LinkedIn account.




Theraclion is listed on Euronext Growth Paris
Eligible for the PEA-PME scheme
Mnemonic: ALTHE - ISIN code: FR0010120402
LEI: 9695007X7HA7A1GCYD29


Theraclion contact

Martin Deterre
Chief Executive Officer
contact@theraclion.com




Page 2 sur 2