MALAKOFF, FRANCE, 26 September 2016 – THERACLION (Alternext, FR0010120402 – ALTHE), a company specialized in leading-edge medical equipment for echotherapy, today announced the results of a study published in the September issue of the International Journal of Hyperthermia. The data are a mid-term assessment of breast fibroadenoma volume and pain following circumferential treatment with Theraclion’s Echopulse®. Theraclion also announced results from two studies collectively demonstrating that Echopulse® high intensity focused ultrasound (HIFU) technology effectively reduces thyroid nodule volume and appears to be safe and well-tolerated. These data were presented at the 39th Annual Meeting of the European Thyroid Association (ETA) in Copenhagen and Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2016 Congress in Barcelona.

Positive mid-term results in International Journal of Hyperthermia
The study, entitled “High intensity focused ultrasound in the treatment of breast fibroadenomata: results of the HIFU-F trial,” demonstrated the effectiveness of Echopulse® in the circumferential treatment of breast fibroadenoma compared to an observational cohort. Conducted by Professor Michael Douek’s team in the Breast Surgery department of Guy’s and St. Thomas University Hospital, London, UK, the study evaluated 40 patients with breast fibroadenoma; 20 were treated circumferentially with Echopulse® HIFU compared to 20 receiving watchful waiting. All patients were assessed before the treatment performed with Echopulse® and after the end of follow-up period.


Results of the study showed that:

• Breast fibroadenoma volume was significantly reduced by 43.5% after the echotherapy procedure;
• Mean volume reduction between the two groups was significantly in favor of the echotherapy (HIFU) group;
• Pre-treatment pain was completely resolved in 75% of echotherapy patients;
• Circumferential ablation reduced the mean treatment time by 37.5% compared to the standard protocol;
• Circumferential ablation is feasible, and is a simple, non-invasive, outpatient based alternative to surgical excision;
• In terms of safety, no serious side effects related to the procedure were reported, in line with the acute observations.

Michel Nuta, M.D., Theraclion Chief Medical Officer, said: “The results of this trial confirm the efficacy of circumferential treatment for the indication of breast fibroadenoma with significant treatment time reduction. In addition, for the first time, comparative results versus a control group are available and reinforce the quality of the outcomes previously published in un-controlled cohorts. We are continuing our clinical research programs for establishing Echopulse® as a modern standard of care.”

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