Theraclion Successfully Completes Pivotal Study with 96.8% Occlusion Rate

Theraclion announced the results of its VEINRESET study, involving Sonovein®, its non-invasive varicose vein treatment platform. With an occlusion rate of 96.8% at 12 months, the clinical trial demonstrated strong efficacy. Only one mild adverse event was reported, highlighting an excellent safety profile.

The reflux abolition rate reached 98.5%, demonstrating the effectiveness of high-intensity focused ultrasound (HIFU). The study enrolled 70 patients at various centers, including New York and Vienna. The results will inform the FDA's application for approval, paving the way for access to the US market.

Patients reported a reduction in pain and symptoms. Investigators expressed satisfaction with the results, promising a reliable, non-invasive alternative to existing treatments.