Theraclion Set to Initiate Pivotal Study of Sonovein Echotherapy in Varicose Veins

April 17, 2023—Theraclion, a France-based company developing a scalable robotic platform for noninvasive ultrasound therapy, announced that the FDA has approved its investigational device exemption application to initiate the multicenter pivotal VEINRESET study of the treatment of primary insufficiency of great saphenous veins with the company’s Sonovein echotherapy device.

According to Theraclion, the company’s echotherapy technology uses high-intensity focused ultrasound, which concentrates therapeutic ultrasounds to an internal focal point from outside of the body. Echotherapy does not require incisions or an operating room, leaves no scars, and allows patients an immediate return to their daily activities.

The pivotal VEINRESET study will be conducted in four centers in the United Stated and in Europe. Patient treatments are planned to start later this year. The study’s Principal United States Investigator is Steven Elias, MD, the director of the Center for Vein Disease at Englewood Hospital in Englewood, New Jersey.

Results of the United States feasibility trial of the Sonovein device were announced by the company on February 3, 2023.

“We believe that this key study will confirm the positive findings of the FDA feasibility study, completed just 2 months ago, and will ultimately allow us to commercially address the United States market,” stated Theraclion’s executive chairman Yann Duchesne in the press release.

Two Theraclion robotic platforms delivering echotherapy have received CE Mark approval: the Sonovein for varicose veins and Echopulse for breast fibroadenoma and thyroid nodules, noted the company.