Theraclion has announced US Food and Drug Administration (FDA) approval for the first trial with Sonovein in the USA. 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 will be led by Steve Elias (nglewood Health Network, Englewood, USA). The study will be conducted in collaboration with Nicos Labropoulos and Antonios Gasparis (both Stony Brook University Hospital, Stony Brook, USA). “We are excited to be the first in the USA 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 Elias.
“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 preclinical studies, the CE marking since 2019 and our clinical data from our European centres should support a fast approval for our pivotal study” said Michel Nuta, chief medical officer and vice president, Veins, Theraclion.