Theraclion’s Sonovein Therapy for Varicose Veins to Be Studied in the United States

September 21, 2021—Theraclion SA, a France-based company specializing in echotherapy using high intensity focused ultrasound, announced that the FDA has approved the first trial with the company’s Sonovein system for the treatment of varicose veins in the United States.

After this initial clinical trial, a full pivotal study will be conducted for FDA review to obtain market authorization. Sonovein, which is based on the company’s Echopulse technology, received European CE Mark approval in April 2019.

According to the company, the study will be initiated as soon as possible and will be led by Steve Elias, MD. The study will be conducted in collaboration with Professor Nicos Labropoulos, PhD, and Antonios Gasparis, MD.

Dr. Elias commented in the company’s press release, “We are excited to be the first in the United States to assess this breakthrough technology, which takes superficial vein treatment to the next level: completely noninvasive and transcutaneous. It will be great for patients.”

Michel Nuta, MD, Theraclion’s Chief Medical Officer and Vice President, Veins, stated, “We are proud that Sonovein, our technology, was chosen to be assessed by renowned experts in vein treatments. We are hoping to have soon the first United States patients treated with our extracorporeal system for their varicose veins. Our qualitative preclinical studies, the CE marking since 2019 and our clinical data from our European centers should support a fast approval for our pivotal study.”