Theraclion Advances Toward U.S. Market Entry for Sonovein
Theraclion announced on Monday the approval by the American Medical Association of a new billing code (Category III CPT) for non-invasive treatment of varicose veins using high-intensity focused ultrasound with its Sonovein platform. This code, effective from January 1, 2027, is a crucial element for accessing the U.S. market alongside the FDA approval application.
Regulatory Recognition for U.S. Commercial Strategy
According to CEO Martin Deterre, the creation of this billing code represents a 'major step' for Theraclion's U.S. strategy. Category III codes are intended for emerging medical technologies and procedures; they facilitate the reporting of performed procedures, monitoring of clinical use, and collection of evidence. This mechanism is expected to support future discussions with healthcare providers, payers, and clinical researchers as Theraclion prepares for potential commercialization in the U.S.
FDA Decision Expected by Late 3rd/Early 4th Quarter 2026, Commercial Launch Targeted
Theraclion's FDA approval application was submitted in December 2025 under the De Novo pathway, following a pivotal study demonstrating 96.8% efficacy. Interactions with the agency are progressing 'constructively,' and a decision is anticipated by the end of the third quarter or the beginning of the fourth quarter of 2026. Theraclion is concurrently executing its commercial launch preparations, with market entry targeted for the end of 2026.
Limited Scope of the Billing Code
The approval of the CPT code by the AMA's editorial panel does not constitute an endorsement of any specific technology, nor does it guarantee coverage or payment. Payment, coverage, and coding policies remain subject to the decisions of individual payers.
