According to Frey Medical's announcement, the company's shareholder SONOVEIN®, France's core product, obtained a marketing license granted by the US FDA through the DeNovo channel on November 4, 2026, making it the first and only non-invasive high-intensity focused ultrasound platform approved for varicose veins treatment in the US. The company holds 27.70% of Tyracleon's shares. This approval does not change the shareholding ratio and scope of consolidated statements, nor does it directly generate revenue.

According to Frey Medical's announcement, the company's shareholder SONOVEIN®, France's core product, obtained a marketing license granted by the US FDA through the DeNovo channel on November 4, 2026, making it the first and only non-invasive high-intensity focused ultrasound platform approved for varicose veins treatment in the US. The company holds 27.70% of Tyracleon's shares. This approval does not change the shareholding ratio and scope of consolidated statements, nor does it directly generate revenue.