Theraclion Announces 2023 Financial Results and Continues Its Roadmap

Regulatory News:

THERACLION (ISIN : FR0010120402 ; Mnemo : ALTHE), an innovative company developing a robotic platform for non-invasive high-intensity focused ultrasound (HIFU) therapy, presents its 2023 financial results and reviews the execution of its strategy.

U.S. pivotal study underway

An initial feasibility study in 2022 showed 100% feasibility and 95% absence of venous reflux. A larger pivotal study began in October 2023. A larger pivotal study, designed to accelerate entry into the world's leading varicose vein treatment market, began in October 2023. Treatment has begun at the four study centers in Europe and the United States, and over two-thirds of patients have been treated to date. Study results will be available after a 12-month follow-up period, in accordance with the protocol approved by the Food & Drug Administration (FDA). U.S. marketing authorization is expected following review by early 2026.

The foundations of value creation: R&D and AI

Significant progress has been made in developing new technological building blocks, notably in artificial intelligence, robotics and acoustics. By combining the system’s real-time imaging capabilities with robotics, AI algorithms will be implemented in order to automate certain tasks, speed up procedures and considerably simplify interactions between physicians and SONOVEIN. At the same time, partnerships with a dozen reference centers in Europe are continuing (some of them already account for 100 to 150 treatments a year), improving treatment protocols and contributing to the rapid advancement of the technology. Concrete milestones in transformative improvements to SONOVEIN are expected over the next two years.

A successful capital increase

A capital increase of €8.4 M was carried out at the end of May, mainly thanks to the historical shareholders, including notably Furui, a Theraclion SA shareholder since 2016. In addition to an initial investment of €6 M, Furui has committed to further funding of €1 M, subject to Theraclion meeting specific operational targets. An initial payment was made following the launch of the pivotal study in the United States.

A new partner to accelerate access to the Chinese market

Close collaboration has been established between Furui and Theraclion in order to conquer the Chinese market. Theraclion has licensed its technologies and brands to Theraclion China, the pre-existing joint venture between the two companies, in return for €3 M fee. Theraclion China was consolidated and restructured in 2023 in order to actively launch its execution plan in early 2024. These advances enabled €2 M in license royalties to be invoiced to Theraclion China for Echopulse and SONOVEIN at the end of 2023.