Regulatory News:

THERACLION (ISIN: FR0010120402; Mnemo: ALTHE), an innovative company developing a robotic platform for non-invasive high-intensity focused ultrasound (HIFU) therapy, announces today that its latest generation SONOVEIN® ‘SpeedPulse’ feature is being tried on patients.

Major R&D breakthroughs in recent months

SONOVEIN® achieved a new level of maturity in 2024, with Theraclion maintaining its focus on ongoing R&D and innovation. Key progress has recently been made on the development of new functionalities, particularly in Artificial Intelligence, acoustics and 3D robotics, boosting clinical efficacy and treatment speed. These advancements will drive broader adoption in treatment centers, expanding the addressable market and reinforcing Theraclion’s mid-term growth potential.

SONOVEIN® ‘SpeedPulse’ significantly reduces treatment time

As part of these major enhancements, a clinical trial has started in Prague, Czech Republic, at the end of January 2025. The tested feature called ‘SpeedPulse’ integrates improved acoustics and therapeutic ultrasound pulsing, aiming at substantially increasing treatment speed. The trial will span over several months.

Prof. Jaroslav Strejček, head investigator of the trial, declared: “As an early adopter of the SONOVEIN®, I’m excited to see the SpeedPulse feature being developed. During the first patient treatments with the SpeedPulse, we have already observed dramatic potential for shortening the treatment duration. This innovation brings significant value to an already groundbreaking technology, further enhancing SONOVEIN®’s competitiveness against existing varicose veins treatment methods.”

The commercialization of SONOVEIN® ‘SpeedPulse’ is planned to start after the trial and completion of the regulatory approval process.

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 enables patients to return to their daily activities immediately. The HIFU treatment method concentrates therapeutic ultrasounds on an internal focal point from outside the body.

Theraclion develops the HIFU, CE-marked, platform for varicose veins treatment SONOVEIN®, which has the potential to replace millions of surgical procedures every year. In the United States, SONOVEIN® is an investigational device limited to investigational use; it is not available for sale in the U.S.

Based in Malakoff (Paris), the Theraclion team is made up of some 30 people, most of them involved in technological and clinical development.

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

Martin Deterre Chief Executive Officer contact@theraclion.com

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