Theraclion announced that the U.S. Food & Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) application, enabling the initiation of the VEINRESET multi-center pivotal study for the treatment of primary saphenous vein insufficiency with SONOVEIN®.

The pivotal study will be conducted at four centers recognized for their scientific excellence in the U.S. and Europe. Treatment of patients is scheduled to begin later this year.

' The approval of this clinical trial is a key step in Theraclion's commercial strategy, as the North American market represents over 45% of the global market and is the prescriber for the rest of the world. Prices are higher in the U.S. than in Europe, enabling a more homogeneous market access strategy and, consequently, faster penetration', says the group.

The number of annual procedures for the treatment of varicose veins worldwide is expected to reach 4.3 million by 2033, representing a potential market of $2.1 billion for Theraclion, adds management.

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