Theraclion’s Sonovein Clinical Trial Completes Enrollment

October 17, 2022—Theraclion, a France-based developer of a scalable robotic platform for noninvasive ultrasound therapy to treat varicose vein disease, announced that the final patient was enrolled and treated in the first study in the United States of the company’s Sonovein system. The Sonovein HD robotic platform integrates high-definition Mach 30 10-12 Mhz ultrasound imaging system with high-intensity focused ultrasound to completely and noninvasively obliterate the source of venous reflux.

The company announced this milestone as well as the presentation of early trial results at AVLS 2022, the 36th annual congress of the American Vein and Lymphatic Society held October 13-16 in New Orleans, Louisiana.

According to Theraclion, 20 patients were enrolled in this clinical trial. The trial was conducted by Principal Investigator Steve Elias, MD, with Nicos Labropoulos, PhD, and Antonios Gasparis, MD.

At AVLS, Dr. Elias reported that 19 of 20 (95%) patients had no reflux at the 1-week interval. At the completion of the study at the 3-month interval, 10 of 10 patients had no reflux. There were no reported adverse events. All patients were treated without local or tumescent anesthesia. No postprocedure compression was used, stated the company.

During the congress, Dr. Elias noted that Sonovein HD enabled faster treatment than previous generations and that he “only needed his pencil and his ultrasound gel” to treat his patients. He also stated that all treated patients would recommend it to others, adding, “This highlights that patients can be treated sitting in an exam chair and return to normal activity immediately.”

Michel Nuta, MD, Chief Medical Officer at Theraclion, commented in the company’s press release, “A 95% success rate, taking the learning curve into account, is very encouraging and reflects well the great clinical and technical developments behind Sonovein HD.”

After the closure of this clinical trial, the company expects to conduct a full pivotal study for FDA review to obtain market authorization.

In September 2021, the company announced FDA approval of the trial.

Sonovein received European CE Mark approval in April 2019 to treat varicose veins. The company’s other echotherapy platform is the CE Mark–approved Echopulse to treat breast fibroadenomas and thyroid nodules.