EDAP TMS SA

FocalTherics is a medical technology company that develops, manufactures, markets, and sells non-invasive therapeutic ultrasound and energy-based medical devices. The company was founded in 1979 as a *société anonyme* (a type of public limited company) organized under French law for a duration of 60 years from its incorporation date, unless extended by shareholder approval. FocalTherics is headquartered in Vaulx-en-Velin, France, and operates in the United States, Europe, Asia, and the rest of the world. Its technologies are primarily used in urology, with a current focus on treating prostate cancer. FocalTherics is conducting clinical development activities to support potential expanded indications in urology and women's health. The company has realigned its business to focus exclusively on applications leveraging its proprietary High Intensity Focused Ultrasound (HIFU) technology, commercially driven by its flagship product, Focal One Robotic HIFU. This realignment aims to position Focal One HIFU as a differentiated platform. Focal One has achieved key regulatory milestones: On June 18, 2013, FocalTherics obtained a CE Marking for Focal One for the treatment of prostate cancer, which allowed its commercialization in the European Union and other territories requiring CE Marking. On June 7, 2018, the company received U.S. regulatory approval for Focal One.