Theraclion Echopulse

Theraclion Concludes SONOVEIN® FDA Pivotal Study Treatments

Theraclion has announced the completion of treatments in the FDA (Food & Drug Administration) pivotal study for SONOVEIN® in the United States, adhering to the scheduled timeline.

In total, 70 patients received Sonovein treatments in the clinical trial, which involved four leading centers in the U.S. and Europe.

Principal investigator Steve Elias MD commented, “I have been involved with many emerging technologies and initial clinical trials. It is very satisfying to have completed the VEINRESET trial treatments using Sonovein. Sonovein is the only extracorporeal, transcutaneous technology capable of treating superficial venous insufficiency. The patient experience and initial results of this trial are extremely promising. I look forward to the final results of the multi-center clinical trial. This has great potential to be an advancement in the management of superficial venous disease.”

Theraclion’s Chief Medical Officer Michel Nuta MD added, “We are happy to have completed the always important recruitment phase and to have reached the FDA target for treatment numbers. We will now focus on the study follow-up phase and continue accumulating valuable clinical experience in our top-notch centers.”

Following the successful feasibility study in 2022, the FDA pivotal study started as planned at the end of 2023. With the treatment phase concluded, the 12-month follow-up period is now commencing, and results are expected in the summer of 2025. The market approval application will be submitted to the FDA as soon as the study report is available in the second half of 2025, with approval anticipated in early 2026, subject to regulatory review time.

Martin Deterre, CEO of Theraclion, concludes: “We are very satisfied to have reached another key milestone on schedule. We look forward to seeing and presenting the results of this strategic study after the follow-up period next year.”

© Theraclion S. A.

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