Theraclion SA announced that the US Food & Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) application to initiate the multi-center pivotal study VEINRESET for the treatment of primary insufficiency of great saphenous veins with SONOVEIN®. Theraclion's most significant clinical trial to date: The pivotal study will be conducted in four scientifically prominent centers in the United Stated and in Europe. Principal US investigator, Steven Elias, MD, is the director of the Center for Vein Disease at Englewood Hospital, New Jersey, and a Fellow of the American Board of Venous and Lymphatic Medicine and of the American College of Surgeons.

Patients treatments are planned to start later this year. Paving the way to the biggest varicose vein market in the world and beyond: The technology has been endorsed by major key opinion leaders in both the US and Europe and its results have been presented in numerous scientific congresses. This clinical trial approval is a key development in Theraclion's commercial strategy, as the North American market represents more than 45% of the global market, driven by the US.

Compared to Europe, the US is a higher price market and allows for more homogenous market access strategy, and therefore a faster market penetration. In addition, accessing the US market is a major milestone and driver for global sales uptake.