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Theraclion: FDA Accepts To Review Submission For Approval Of Echopulse Trial

Theraclion, a French company specialized in leading-edge medical devices for echotherapy, Wednesday said it has filed a Pre-Submission for discussion with the Food and Drug Administration regarding the regulatory pathway and clinical data requirements for the Echopulse System.

Theraclion intends to conduct a prospective, randomized, multi-center pivotal study of the Echopulse to further evaluate the device for ablation of breast fibroadenoma.

The study will evaluate changes in fibroadenoma volume and symptoms as well as patient satisfaction.

The proposed pivotal study follows two prior investigations, including a European multi-center study in 42 women with 51 breast fibroadenomas. This study demonstrated an average decrease in fibroadenoma volume of 72.5 percent at the 12-month follow-up, with minimal pain and adverse events related to the treatment.

A pilot study is also ongoing at the University of Virginia, Charlottesville, USA, to further evaluate the Echopulse for treatment of breast fibroadenomas.

The data from both studies, together with the proposed pivotal study, will support the company's premarket submission.

The company expects a meeting with the FDA in the third quarter of 2015 to discuss the final design of the clinical study.

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