Theraclion Executes Strategy in First Half

Regulatory News:

THERACLION (ISIN: FR0010120402; Mnemo: ALTHE), an innovative company developing a scalable robotic platform for non-invasive ultrasound therapy, presents its review of the first half of 2023, marked by the achievement of milestones in the deployment of its strategy and the growth of its sales.

Roadmap implementation

In the first half of 2023, Theraclion appointed its new CEO, Martin Deterre, signed a partnership with Furui and secured the necessary funding for the next two years. Theraclion has reached important milestones in the 3 axes of its strategy focused on the treatment of varicose veins:

• Access to the U.S. market: the success of its feasibility study and the FDA's authorization to launch the pivotal multicenter study;
• Access to the Chinese market: the signing in late May of a partnership agreement with Furui to accelerate market access;
• On technological and robotic innovation: significant progress on system development, notably with a view to adding artificial intelligence.

US pivotal study to be launched by the end of the year

Earlier this year, Theraclion announced the success of its U.S. feasibility study, with final results showing a 100% feasibility rate - the trial's primary endpoint - and suppression of venous reflux in 95% of cases. Accelerating its path to the U.S. market, Theraclion recently obtained FDA approval for the launch of the pivotal multi-center study, which will be conducted at four centers recognized for their scientific excellence in the U.S. and Europe. The principal investigator, Steven Elias, MD, Director of the Center for Vein Disease at a prestigious hospital in New Jersey, is a member of the American Board of Venous and Lymphatic Medicine and the American College of Surgeons.

A strategic partnership with Furui to access the Chinese market

A Theraclion SA shareholder since 2016 and co-shareholder of Theraclion China, Furui invested €6 million in the June capital increase of €8.4 million. Its investment will be topped up by a further 1 million euros subject to Theraclion achieving operational targets. Furui and Theraclion also join forces to conquer the Chinese market. Theraclion will license its technologies and the use of its trademarks to Theraclion China, for a 3 million euros fee, to be paid on achievement of milestones.