THERACLION announced the results of the first SONOVEIN(R) trial in the United States, a major milestone towards receiving FDA approval and accessing the US varicose veins market. 100% success rate in the primary end point and 95% abolition of venous reflux The definitive results show a 100% feasibility result, the primary end point of the trial. Patients did not experience any serious adverse event.

Abolition of venous reflux, as measured by duplex ultrasound, was achieved in 95% of cases. The study compliance was 100%, meaning all 80 visits were completed and timely, none lost to follow-up or missed visits. A total of 20 patients were enrolled in this clinical trial approved by the FDA (Food & Drug Administration) in early 2022.

Internationally recognized KOLs Dr Steve Elias, Dr Antonios Gasparis and Dr Nicos Labropoulos conducted this first trial in New Jersey, United States.