Monday, July 15, 2024

Vein Treatment Milestone: Theraclion Completes SONOVEIN® FDA Pivotal Study Treatments on Schedule

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Vein treatment is at the forefront of Theraclion’s innovations. This company, headquartered in Malakoff, Paris, is renowned for its development of a robotic platform specifically designed for non-invasive high-intensity focused ultrasound (HIFU) therapy. Through this cutting-edge technology, Theraclion aims to revolutionize the field of vein treatment, providing effective, non-surgical solutions for patients worldwide.

This method offers a non-surgical alternative that requires no incisions, does not necessitate an operating room, leaves no scars, and allows patients to quickly return to their daily activities. The company’s flagship product, SONOVEIN®, utilizes HIFU technology for the treatment of varicose veins and has the potential to replace millions of surgical procedures annually.

Theraclion Completes FDA Pivotal Study Treatments for Innovative Vein Treatment Technology SONOVEIN®

Theraclion announced the successful completion of treatments in the FDA (Food & Drug Administration) pivotal study for SONOVEIN® in the United States. This milestone marks a significant step forward in the approval process for this innovative vein treatment technology. The study was conducted as planned, adhering to the scheduled timeline, and involved a total of 70 patients.

The clinical trial saw participation from four leading centers located both in the U.S. and Europe. These centers collectively contributed to the comprehensive testing of SONOVEIN®’s capabilities. Dr. Steve Elias, the principal investigator, expressed his satisfaction with the trial’s progress and outcomes. He stated, “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.”

Vein Treatment

Theraclion’s CMO Highlights Completion of Recruitment Phase and FDA Treatment Targets for Vein Treatment Study

Theraclion’s Chief Medical Officer, Dr. Michel Nuta, echoed Dr. Elias’s sentiments, highlighting the importance of completing the recruitment phase and achieving the FDA target for treatment numbers. “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,” Dr. Nuta remarked.

With the treatment phase concluded, the study will now enter a 12-month follow-up period. This phase is crucial for gathering long-term data and assessing the durability and efficacy of the SONOVEIN® treatments. The final results of the study are anticipated in the summer of 2025, following which the market approval application will be submitted to the FDA. If all goes as planned, Theraclion expects to receive FDA approval for SONOVEIN® in early 2026, although the exact timeline will depend on the regulatory agency’s review process.

Martin Deterre, the CEO of Theraclion, expressed his satisfaction with the progress made. “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,” Deterre stated.

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Theraclion’s dedication to pioneering non-invasive medical treatments is evident in its relentless pursuit of innovation and clinical validation. The completion of the SONOVEIN® FDA pivotal study treatments marks a significant achievement for the company and brings it one step closer to offering a groundbreaking alternative to traditional surgical procedures for varicose veins in the United States. As the follow-up phase progresses, the medical community and potential patients alike will be eagerly awaiting the final results, which could herald a new era in the management of superficial venous disease.


Resource: Business Wire, June 24, 2024

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