August 31, 2016 -- MALAKOFF, France--(BUSINESS WIRE)-- THERACLION (Paris:ALTHE) (Alternext, FR0010120402 – ALTHE), a company specialized in leading-edge medical equipment for echotherapy, today announced data from five studies demonstrating that echotherapy continues to show very promising clinical results. Results were presented this week at the 5th International Symposium on Focused Ultrasound (FUS), held August 28 – September 1, 2016 in Bethesda, USA. Theraclion also announced that the U.S. Food and Drug Association (FDA) cleared Theraclion’s request for an Investigational Device Exemption (IDE) for breast fibroadenoma, which will be developed via the 513(f)(2) pathway.
Hosted by the Focused Ultrasound Foundation, the International Symposium on Focused Ultrasound is the single most significant international conference dedicated to high-intensity focused ultrasound (HIFU) therapy, bringing together every year the leading experts, researchers and practitioners in the field, alongside key players in the industry.
“Results from the presented studies continue to demonstrate the very good efficacy and tolerability of echotherapy (US-guided High Intensity Focused Ultrasound - HIFU) as a non-invasive ablative technique for both symptomatic breast fibroadenoma and benign symptomatic thyroid nodule indications,” commented Michel Nuta, M.D., Chief Medical Officer of Theraclion.
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David Caumartin, CEO of Theraclion added, “Through additional clinical trials, including now in the U.S., we believe we will continue to demonstrate the value of the Echopulse® system for physicians and their patients.”
As part of this year’s FUS symposium, the latest results were presented from three studies on the treatment of breast fibroadenoma and two on the treatment of thyroid nodules.
Carrie Rochman, M.D., Assistant Professor of Radiology, under principal investigator Dr. David Brenin, M.D., FACS, Chief of Breast Surgery, Co-director of the University of Virginia Breast Care Program and Associate Professor of Surgery at UVA’s School of Medicine, presented the first U.S. results of treatment with Echopulse® with preliminary findings from an ongoing, single arm, feasibility study (HIFU-FA-001) of 20 female patients diagnosed with palpable breast fibroadenomas (BFAs). Sixteen patients were treated to date. All reported that they would recommend the procedure to a friend or family member. Reduction in the size of the palpable mass was reported by both the patient and evaluating physician in all cases. Data showed that treatment with Echopulse® was well-tolerated by patients with minimal discomfort. There have been no grade 3 adverse events, no skin burns, no persistent changes in skin appearance, and no other significant toxicities/morbidities observed. (Abstract ID: CA-44)