Theraclion’s Sonovein Evaluated in First United States Trial

February 3, 2023—Theraclion, a France-based company developing a scalable robotic platform for noninvasive ultrasound therapy, recently announced the results of the first trial of Sonovein in the United States.

Theraclion’s CE Mark–approved Sonovein robotic platform delivers echotherapy to treat varicose veins. Echotherapy, a high-intensity focused ultrasound method, concentrates therapeutic ultrasounds to an internal focal point from outside of the body. It does not require incisions or an operating room, leaves no scars, and allows patients an immediate return to their daily activities, stated the company.

Theraclion reported that the trial demonstrated 100% feasibility, which was the primary endpoint. Patients did not experience any serious adverse events. Abolition of venous reflux as measured by duplex ultrasound was achieved in 95% of cases.

The company advised that 20 patients were enrolled in the study and had 100% compliance. All 80 visits were completed and timely; no patients were lost to follow-up or missed visits.

The clinical trial was conducted by Principal Investigator Steve Elias, MD, from Englewood Health in Englewood, New Jersey, in collaboration with Nicos Labropoulos, PhD, and Antonios Gasparis, MD.

“I am happy to have finished the first FDA-approved trial with Sonovein in the United States,” commented Dr. Elias in Theraclion’s press release. “More importantly, the results are as good—if not a little bit better—than some of the results with the more traditional technologies. Ninety-five percent of patients had a successful healing of the abnormal vein.”

Dr. Elias continued, “We treat people who have abnormal veins, and not just the veins. Most important, all patients felt better. Sonovein really is the next evolution of a completely noninvasive, transcutaneous way of treating vein diseases. We look forward to being able to offer this to our patients.”

According to Theraclion, completion of the trial is a milestone in the company’s path toward FDA approval to market the technology in the United States. In September 2021, the company announced FDA approval of the trial and advised that a full pivotal study will be subsequently conducted for FDA review to obtain market authorization. In October 2022, enrollment completion was announced by the company.