Theraclion Delivers Its 2023 Strategic Objectives

Regulatory News:

THERACLION (ISIN: FR0010120402; Mnemo: ALTHE), an innovative company developing a scalable robotic platform for non-invasive ultrasound therapy, is now taking stock of its achievements over 2023.

Martin Deterre is appointed Managing Director to accelerate the deployment of the 3-pronged strategy:

• Access to the US market;
• Access to the Chinese market and development of industrial capacity in China;
• Continued product development (artificial intelligence, robotics, improved treatment protocols).

"I am delighted with the major advances achieved in 2023. The start of the pivotal vein study in the United States, the partnership established with the Chinese group Furui, the acceleration in the number of treatments and the achievement of major technological developments all contribute to securing Theraclion's commercial success," said Martin Deterre.

Launch of pivotal study: the United States in sight

The process of gaining access to the colossal US market is proceeding according to plan. The first treatments in the pivotal study took place in the United States in October. Since then, new cases have been treated in Europe. Treatment will continue in the first half of 2024, and results will be known after 12 months' follow-up, in accordance with the protocol approved by the FDA (Food and Drug Administration). Market authorization in the US is envisaged after the FDA's statutory review period, by early 2026.

Partnership with Furui: a new start for the Chinese market

Furui has already invested €6 million in Theraclion by June 2023. Further investments of €4 million are planned: €1 million via exercise of ABSAs and €3 million via licensing rights. A first ABSA exercise for 0.5 M€ was recorded following the launch of the pivotal study in the United States. Theraclion and Furui have also made significant progress over the last 3 months in structuring their joint venture, which will enable access to the high-potential Chinese market and extend production capacity in China.

Innovations in Artificial Intelligence (AI) and robotics

Significant new hardware and software enhancements to the system are deployed in the field as part of the ongoing clinical study and have received excellent feedback from the investigating physicians. Advances made in integrating the latest-generation robotics and AI will facilitate the adoption of the system and improve patient care. These developments will enhance the product's competitiveness and commercial potential, contributing to a considerable appreciation in the company's value.