Theraclion reveals First Patients Treated With SONOVEIN® as Part of the FDA-approved Pivotal Study
Theraclion has officially launched the initial treatments for its pivotal study, which has received FDA approval, on the use of SONOVEIN® for treating varicose veins in the United States.
Theraclion’s strategic focus is on early entry into key markets in the United States and China, and commencing patient treatments marks a crucial milestone in gaining access to the global varicose vein market leader.
The FDA granted approval for this clinical trial a few months ago, building upon a successful feasibility study conducted last year. The highly regarded Dr. Steve Elias, Director of the Center for Vein Disease at a prestigious New Jersey hospital and a member of esteemed organizations like the American Board of Venous and Lymphatic Medicine and the American College of Surgeons, is leading the investigation. This trial will take place at four renowned medical centers in the United States and Europe, with results becoming available following a 12-month follow-up period in accordance with the FDA-approved protocol.
Martin Deterre, CEO, commented “These first patients treated in the pivotal study demonstrate the progress made by the Theraclion team, in a timeline perfectly aligned with our defined strategic roadmap. Enrollment is expected to take several months, with the ultimate goal of U.S. market approval by early 2026.”
Michel Nuta, MD, CMO, Vice President Veins, added “The study aims to enable access to this unique extracorporeal technology, without catheters or artificial chemicals, for U.S. patients in the near future.”