THERACLION announced that treatments in the United States? FDA (Food & Drug Administration) pivotal study for SONOVEIN® have concluded, in accordance with the scheduled timeline. A key milestone in the FDA approval process for SONOVEIN® A total of 70 patients have been treated with Sonovein in the clinical trial.

Four leading centers took part in this study, in the U.S. and in Europe. Results to be released after 12-month follow-up Following the successful completion of a feasibility study in 2022, the FDA pivotal study was initiated on schedule at the end of 2023. With the conclusion of the treatment phase, a 12-month follow-up period is now beginning, and the study results will be available in the summer of 2025.

The market approval application will be submitted to the FDA as soon as the study report becomes available in the second half of 2025, and an approval is expected early 2026 but will depend on the regulatory agency review time.