THERACLION, the company recognized for developing Sonovein®, an innovative robotic platform for the non-invasive treatment of varicose veins using high-intensity focused ultrasound (HIFU), has announced significant advancements in its international expansion. These regulatory achievements strengthen its position in key global markets.
Recently, in Europe, Sonovein® received MDR certification (Medical Device Regulation, EU 2017/745), ensuring compliance with rigorous safety and quality standards. This certification is essential to ensure the commercial continuity of the system in all markets governed by this regulation.
In the United States, the pivotal VEINRESET study, funded by Theraclion, has shown promising results with an occlusion rate of 96.8%. This success not only supports the safety and effectiveness of the non-invasive HIFU treatment but will also serve as a basis for the future submission of authorization to the FDA, the primary regulatory body in the field of venous treatments.
In another significant advancement, Sonovein® successfully achieved GB 9706.1-2020 certification in China, a crucial step toward market authorization in one of the world’s most dynamic sectors. This recognition, obtained from the National Medical Products Administration (NMPA), positions Theraclion even more prominently on the global stage.
Martin Deterre, CEO of Theraclion, emphasized that these certifications are the result of years of effort and dedication, representing a turning point for the company. “They allow us to move confidently towards our goal of providing a global therapeutic solution for millions of patients suffering from varicose veins worldwide,” stated Deterre.
Thanks to these achievements, Sonovein® has positioned itself as a preferred option, offering doctors and patients a non-invasive alternative to traditional varicose vein surgery. To date, more than 3,500 procedures have been performed in Europe and the Middle East, with adoption in over a dozen healthcare centers.
With these significant advancements, Theraclion solidifies its position as a leader in the non-invasive treatment of varicose veins and accelerates its international expansion, bringing the benefits of Sonovein® to an increasing number of patients and healthcare professionals.
Theraclion is a French medical company focused on innovation in the treatment of varicose veins through the use of focused ultrasound. This non-invasive technology not only avoids incisions and scars but also allows patients to quickly return to their daily routines, thus improving their quality of life.
Referrer: MiMub in Spanish