Theraclion’s Sonovein Pivotal Study Completes Enrollment

June 24, 2024—Theraclion, a France-based company developing a robotic platform for noninvasive high-intensity focused ultrasound (HIFU) therapy, announced the conclusion of treatments in VEINRESET, the United States’ pivotal study for Sonovein.

Sonovein is Theraclion’s CE Mark–approved HIFU platform for treating varicose veins. In the United States, the Sonovein platform is limited to investigational use and is not available for sale.

According to the company, a total of 70 patients have been treated with Sonovein in the clinical trial at four centers in the United States and Europe. Steve Elias, MD, is Principal Investigator of the trial.

“I have been involved with many emerging technologies and initial clinical trials,” commented Dr. Elias in Theraclion’s press release. “It is very satisfying to have completed the VEINRESET trial treatments using Sonovein.”

According to the company, the pivotal study was initiated at the end of 2023. The company stated that enrollment concluded in accordance with the scheduled timeline for its FDA-approval process for Sonovein.

Now, a 12-month follow-up period is beginning. The study results will be available in the summer of 2025.

The premarket approval application will be submitted to the FDA as soon as the study report becomes available in the second half of 2025. An approval is expected in early 2026, depending on the regulatory agency review time, advised Theraclion.