Theraclion has secured FDA (Food & Drug Administration) approval for the first trial with SONOVEIN in the United States (US). After this clinical trial, a full pivotal study will be conducted for FDA review for market authorisation.
The study will be initiated as soon as possible and conducted in a well-known New Jersey Center by Steve Elias MD FACS DABVLM, an internationally recognized vein specialist with more than 30 years experience in the treatment of venous disease. The study will be conducted in collaboration with Dr Nicos Labropoulos and Dr Antonios Gasparis both internationally recognized vein specialists with more than 30 years experienced too.. “We are excited to be the first in the US to assess this breakthrough technology which takes superficial vein treatment to the next level: completely non-invasive and transcutaneous. It will be great for patients” said Dr Steve Elias, MD FACS DABVLM.
“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 US patients treated with our extra corporeal system for their varicose veins. 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 Theraclion SA.
It is a crucial milestone for Theraclion to access the largest market for varicose veins with an estimated 2,3 million procedures representing healthcare spending of $ 5 Billion. It has historically been under penetrated but will expand with the development of painless and non-invasive technologies such as SONOVEIN.
SONOVEIN is the only non-invasive option, without scars and without incisions. The advanced technological solution allows optimal treatment procedure in a reduced duration and improves patient experience.