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Sonovein Varicose Vein Studies Move Forward on Pathway to FDA Approval

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Ari Kellen is a longtime New Jersey entrepreneur who provides strategic advisory and investment solutions to early stage growth companies. As a board member of Theraclion, Ari Kellen serves on the board of this French company that has developed the medical platform Sonovein as a non-invasive, robot-enabled means of treating varicose veins.

At the American Venous Forum’s 2023 annual meeting in February, Stony Brook University professor Antonis Gasparis announced the conclusion of Sonovein’s first ever US trial of this emerging treatment. As part of the study, 18 patients received treatment for 20 great saphenous veins through a high-intensity focused ultrasound (HIFU) approach. No complications were reported and none of the patients received anesthesia or post-procedure compression. Venous reflux ablation was achieved in 95 percent of the cases.

In April, the MedTech company received an investigational device exemption (IDE) for a pivotal study. Spanning centers in the US and Europe, this multi-center study will assess a robotic solution that can be operated by a physician in a non-sterile environment. Theraclion hopes to offer HIFU as a different approach to treating varicose veins from currently available, more invasive therapies.