Theraclion publishes investor presentation on Sonovein HIFU platform for varicose vein treatment

  • Theraclion outlined plans to scale Sonovein, a fully robotic HIFU system for non-invasive varicose vein treatment, targeting global commercialization.
  • FDA De Novo filing made in Dec. 2025; US clearance targeted for Q3/Q4 2026, supported by a CPT Category III code starting Jan. 1, 2027.
  • VEINRESET pivotal study showed 96.8% vein occlusion at 12 months in 70 patients; zero serious adverse events reported.
  • Group cited a USD 13 billion varicose vein treatment market with 6.5% annual growth; over 10 million procedures per year globally.
  • Commercial model centers on pay-per-use subscriptions or device sales with single-use consumables; EBITDA breakeven projected at about 100 machines deployed.


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