First data generated in U.S. support Theraclion’s Echotherapy system

First data generated in U.S. support Theraclion’s Echotherapy system

Press releases may be edited for formatting or style | August 31, 2016 Ultrasound

Michael Douek, M.D., Professor of Surgical Oncology and Breast Surgeon, presented interim results to date of an ongoing, single-arm study (HIFU-F) of 50 female patients diagnosed with symptomatic, palpable breast fibroadenoma. Interim results demonstrated that circumferential HIFU ablation of fibroadenoma with Echopulse® is feasible, with a significant reduction in volume compared to control patients, and provided a simple, non-invasive, outpatient-based alternative management option for the condition. For the 20 patients treated with Echopulse® in the study to date, results showed a significant mean reduction in fibroadenoma volume of 43.5%, compared to a 4.6% reduction in volume observed in the control group at six months. Circumferential ablation significantly reduced the mean treatment time by 37.5% compared to whole lesion ablation. In addition, six of eight patients who experienced pre-treatment pain had complete resolution of symptoms six months post-treatment. (Abstract ID: CA-46)

Brian Lang, M.D., Clinical Associate Professor of the University of Hong Kong and Chief of Endocrine Surgery of Queen Mary Hospital and Tung Wah Hospital, presented results of an ongoing, prospective, single-arm study of 22 patients with benign symptomatic thyroid nodules. Results demonstrated that ultrasound-guided HIFU ablation with Echopulse® is an effective and safe treatment option for patients with benign symptomatic thyroid nodules and has the potential to improve the health-related quality of life of patients who do not wish to undergo surgical resection. Of the 22 patients treated with Echopulse® at six months following echotherapy, the average treated nodule volume reduction was 71.58% ± 11.81%. The study also showed a significant improvement in all quality-of-life domains, including sleep quality, daytime sleepiness, mood state, anxiety, depression, as well as the physical component of the SF-12 Physical and Mental Health Summary Scale. (Abstract ID: CA-50)

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Roussanka Kovatcheva, M.D., Professor of Endocrinology at the University Hospital of Endocrinology of Sofia, Bulgaria, presented highly promising results from two studies:

An ongoing, prospective, single-arm study of 20 patients evaluating the long-term efficacy and tolerability of treatment of breast fibroadenoma with Echopulse®. The results showed that fibroadenoma volume decreased significantly at one-month and three-month follow-up, respectively, and continued to decrease at 24-month follow-up. At 24 months, mean volume reduction was 77.32% in group 1 (1 echotherapy session) and 90.47% in group 2 (two echotherapy sessions). (Abstract ID: CA-45)

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