Theraclion Announces First Clinical Deployment of Sonovein® in Hainan, China

MALAKOFF, France--(BUSINESS WIRE)--Regulatory News:

THERACLION (ISIN: FR0010120402 – Mnemo: ALTHE), an innovative company developing a robotic platform for non-invasive therapy using high intensity focused ultrasound (HIFU) for the treatment of varicose veins, announces a significant milestone in its China expansion strategy with the deployment of a SONOVEIN® system at Boao Super Hospital in Hainan Province supported by its Joint Venture with its strategic partner Inner Mongolia Furui Medical Science Co., Ltd.

Sonovein® marks its first clinical footprint in China

The deployment follows the recent granting of authorization for SONOVEIN® to be used as an urgently needed imported medical device within Boao Super Hospital in the Boao Lecheng International Medical Tourism Pilot Zone. This regulatory framework has been established by Chinese authorities to facilitate early access to innovative foreign medical technologies which are licensed abroad but not yet available in China. The Hainan Boao Lecheng Pilot Zone operates under a specific regulatory framework, distinct from the standard National Medical Products Administration (NMPA) registration process, while remaining under close regulatory supervision.

The SONOVEIN® system was delivered to the clinical site in May 2026, with first patient treatments expected to begin in the coming weeks.

Strong cross-border collaboration

The project was carried out in close collaboration with Theraclion's Chinese teams from its Shenzhen-based Joint Venture with Furui, highlighting the strong cooperation between the Company's teams in China and France.

Martin Deterre, Chief Executive Officer of Theraclion, commented: "We are extremely excited to see SONOVEIN® reaching this important milestone in China. This deployment in Hainan is the result of outstanding collaboration between our teams in Malakoff and Shenzhen, who have worked hand in hand to bring this project to life. We are proud to see our technology entering clinical practice in one of China's most innovative healthcare environments. This achievement paves the way for broader adoption of Sonovein® in China and reinforces our confidence in the tremendous potential of this market."

Regarding Theraclion’s regulatory activities in mainland China, the company successfully completed the required technical testing phase and submitted its NMPA registration dossier at the end of 2025. Discussions with Chinese regulatory authorities are ongoing as part of the review process. The Company continues to work closely with its strategic partner Inner Mongolia Furui Medical Science Co., Ltd. and its local teams to support future commercialization activities in China.

A major market opportunity

China represents one of the world's largest markets for the treatment of venous disease, with millions of patients affected by chronic venous insufficiency and varicose veins. Theraclion believes that the combination of Sonovein®'s unique non-invasive profile and growing physician interest in HIFU technologies positions the Company favorably for future development opportunities in the region.

About Theraclion

Theraclion is a French MedTech company 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 allows patients to resume normal activities immediately. HIFU concentrates therapeutic ultrasound on an internal focal point from outside the body.
Theraclion is developing Sonovein®, a robotic HIFU platform for varicose vein treatment, CE marked under the MDR (EU 2017/745), with the potential to replace millions of surgical procedures each year. To date, Sonovein® has been adopted by more than a dozen centers worldwide and used in over 4,000 procedures. In the U.S., Sonovein® is not yet available for sale.
Based in Malakoff (Paris), Theraclion’s team comprises around 35 people.

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
Ticker: ALTHE - ISIN Code: FR0010120402
LEI: 9695007X7HA7A1GCYD29