Theraclion, a French MedTech company developing a robotic platform for non-invasive high-intensity focused ultrasound (HIFU) therapy, announces today that treatments in the Food and Drug Administration (FDA) pivotal study for Sonovein, an extracorporeal medical device made to treat varicose veins using HIFU, have concluded, in accordance with the scheduled timeline.
A total of 70 patients have been treated with Sonovein in the clinical trial across four leading centers in the US and in Europe.
Principal investigator Steve Elias (Englewood, USA) commented, “I have been involved with many emerging technologies and initial clinical trials. It is very satisfying to have completed the VEINRESET trial treatments using Sonovein. Sonovein is the only extracorporeal, transcutaneous technology capable of treating superficial venous insufficiency. The patient experience and initial results of this trial are extremely promising. I look forward to the final results of the multi-center clinical trial. This has great potential to be an advancement in the management of superficial venous disease.”
Theraclion’s Chief Medical Officer Michel Nuta added, “We are happy to have completed the always important recruitment phase and to have reached the FDA target for treatment numbers. We will now focus on the study follow-up phase and continue accumulating valuable clinical experience in our top-notch centers.”
The study results will be released after a 12-month follow-up.
Following the successful completion of a feasibility study in 2022, the FDA pivotal study was initiated on schedule at the end of 2023. With the conclusion of the treatment phase, a 12-month follow-up period is now beginning, and the study results will be available in the summer of 2025. The market approval application will be submitted to the FDA as soon as the study report becomes available in the second half of 2025, and approval is expected by early 2026 but will depend on the regulatory agency review time.
Martin Deterre, CEO of Theraclion, concludes, “We are very satisfied to have reached another key milestone on schedule. We look forward to seeing and presenting the results of this strategic study after the follow-up period next year.”
