(News Bulletin 247) – Theraclion has announced that the US Food & Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) request, allowing the initiation of the pivotal multicenter VEINRESET study for the treatment of primary insufficiency of the great saphenous veins with SONOVEIN®.
The pivotal study will be conducted at four centers recognized for their scientific excellence in the United States and Europe. Treatment of patients is expected to begin later this year.
“The approval of this clinical trial is a key step in Theraclion’s commercial strategy, since the North American market represents more than 45% of the global market and is a prescriber for the rest of the world. Prices are higher in the United States than in Europe, which allows for a more homogeneous market access strategy and, consequently, faster penetration,” the group indicates.
The number of annual varicose vein treatment procedures worldwide is expected to reach 4.3 million in 2033, representing a potential market of $2.1 billion for Theraclion, adds management.
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