The clinical trial used as a basis for the submission to the European regulatory agencies included USA and UK sites in which 66 patients received one treatment. Post treatment average reduction of approximately 2.5 cm in circumference was observed in the study. Overall, more than 300 people have been treated with the device to date, in the USA, UK, Japan and Israel, demonstrating the safety and efficacy of the treatment.
UltraShape Inc., a developer of non-invasive devices for aesthetic medicine, announced that it has received CE clearance for its first product, the Contour I, for non-invasive long-term body contouring. Ultrashape intends to start selling its product in Europe, Asia and the Pacific region immediately, followed by a formal market launch in the fall. Distribution agreements in several countries were already signed and initial purchase orders for several millions dollar have been received.
The UltraShape technology is based on focused ultrasound, which is claimed to selectively destruct fat cells without damaging any other tissue. The device can be used in an office environment by a trained technician under the supervision of a physician, guided by a state- of- the-art, real-time video-based technology.