THERACLION, an innovative company developing a scalable robotic platform for non-invasive echotherapy, has announced the treatment of varicose veins patients with SONOVEIN for the first time in the United States (US).
The study has been approved by the FDA (Food and Drug Administration) a few months ago. Since then, Theraclion has installed its state-of-the-art SONOVEIN platform and trained physicians. The first patients have been treated by Dr Steven Elias, Dr Nicos Labropoulos and Dr Antonios Gasparis, all three internationally recognized vein specialists with more than 30 years of experience.
“After this clinical trial, a full pivotal study will be conducted for FDA review in view of the market authorisation. Our qualitative pre-clinical studies, the CE marking since 2019 and our clinical data from our European centers should support a fast approval for our pivotal study” said Michel Nuta, MD, Chief Medical Officer, Vice President Veins at Theraclion SA.
This trial is in line with Theraclion’s strategy to focus on key markets. The US is the largest market for varicose veins with an estimated 2.3 million procedures representing a $5 Billion healthcare spending.
SONOVEIN is the only non-invasive option for varicose veins. It does not require incisions, leaves no scars and allows patients an immediate return to daily activities. This advanced technological solution unleashes new treatment opportunities and improves both patient’s and physician’s experiences.